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Midodrine hydrochloride: FDA Proposes Withdrawal of Low Blood Pressure Drug
August 17, 2010
Companies failed to provide evidence of clinical benefit of midodrine hydrochloride because required post-approval studies that verify the clinical benefit of the drug have not been done.
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6 French Engage Introducer Devices by St. Jude Medical: Recall - Potential for Separation of Shaft From Hub
August 17, 2010
Prolatis’: Undeclared Drug Ingredient
August 17, 2010
Product marketed as dietary supplement contains undeclared sulfoaildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.
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Lamictal (lamotrigine): Label Change - Risk of Aseptic Meningitis
August 17, 2010
Warnings and Precautions section of Prescribing Information and patient Medication Guide revised to include information about the risk of aseptic meningitis.
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Novacare LLC Products: Recall - Undeclared Drug Ingredient
August 17, 2010
Products marketed as dietary supplement sexual enhancers for men contain undeclared sulfoaildenafil, which may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
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Combat Application Tourniquets (C-A-T): Suspected Counterfeit Product
August 17, 2010
Suspected counterfeit product is weaker, and breaks or bends before necessary force can be applied to stop blood flow. Excessive blood loss can endanger the victim’s life and ultimately lead to death.
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Inferior Vena Cava (IVC) Filters: Initial Communication: Risk of Adverse Events with Long Term Use
August 17, 2010
Known long term risks associated with IVC filters include lower limb deep vein thrombosis, filter fracture, filter migration, filter embolization and IVC perforation.
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Solo Slim, Solo Slim Extra Strength: Recall - Undeclared Drug Ingredient
August 17, 2010
Product contains undeclared didesmethyl sibutramine, which may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
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Revivexxx Extra Strength: Recall - Undeclared Drug Ingredient
August 17, 2010
Product marketed as a dietary supplement sexual enhancer for men contains undeclared tadalafil, which may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels.
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Nimodipine Oral Capsules: Medication Errors - IV Administration May Result in Death, Serious Harms
August 17, 2010
IV injection can result in cardiac arrest, severe falls in blood pressure, and other heart-related complications.
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NeoProfen (ibuprofen lysine) Injection: Recall and Shortage - Risk of Particulate Matter
August 17, 2010
Afluria (CSL Ltd.) Influenza Virus Vaccine: Label Change - Risk of Fever and Febrile Seizure
August 17, 2010
Increased incidence of fever and febrile seizure among young children reported in Australia, mainly among those less than 5 years of age.
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Miracle Mineral Solution (MMS): Product as consumed produces a potent bleach
August 17, 2010
Product sold online as a dietary supplement. When consumed as instructed, produces an industrial bleach that can cause serious harm to health.
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Nutraloid Labs ejaculoid XXTREME and stimuloid II: Undeclared Drug Ingredient
August 17, 2010
These products, marketed as dietary supplements, contain sulfoaildenafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerously low levels.
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Evamist (estradiol transdermal spray): Drug Safety Communication - Unintended Exposure of Children and Pets to Topical Estrogen
August 17, 2010
Reports of adverse effects in children who may have been unintentionally exposed to the drug through skin contact with women using this product.
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Cubicin (daptomycin): Drug Safety Communication - Risk of Eosinophilic Pneumonia
August 17, 2010
Cases of serious, potentially fatal pneumonia associated with the IV antibacterial drug Cubicin.
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Joyful Slim Herb Supplement : Recall-Undeclared Drug Ingredient
July 26, 2010
Product contains sibutramine; may increase blood pressure/pulse rate with risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, stroke.
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Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays
July 26, 2010
CONSTELLATION Vision System: Recall
July 21, 2010
Software and hardware problems associated with unexpected system loss of power, unintended system error messages, unresponsive touchscreens, and system setting and infusion performance problems.
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Vialipro Dietary Supplement: Recall-Undeclared Drug Ingredient
July 21, 2010
Lab analyses found that certain batches of Vialipro contain Sulfoaildenafil, an analogue of Sildenafil.
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Slim- 30 Herb Supplement: Undeclared Drug Ingredient
July 21, 2010
Advair Diskus (fluticasone propionate and salmeterol inhalation powder): Stolen Product Warning
July 21, 2010
Certain inhalers stolen from a distribution warehouse in 2009 have been found in some pharmacies. The safety and effectiveness of the stolen inhalers cannot be assured and they should not be used.
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Angiotensin Receptor Blockers (ARBs): Ongoing Safety Review for Cancer Risk
July 21, 2010
A recently published study suggested use of ARBs may be associated with a small increased risk of cancer.
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Coumadin 1 mg Tablet Blister Packs: Recall
July 14, 2010
Some tablets may not meet specification for isopropanol, which could affect therapeutic levels of the active ingredient.
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Arava (leflunomide): Boxed Warning - Risk of Severe Liver Injury
July 14, 2010
Air- or Gas-Pressurized Spray Devices: Risk of Air or Gas Embolism
July 14, 2010
Reports of life-threatening air or gas embolism occurring during or immediately after application of hemostatic drug or biological products.
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Que She Herbal Supplement: Undeclared Drug Ingredients
July 14, 2010
Herbal product, sold as weight loss supplement, contains unlisted active pharmaceutical ingredients. Risk of serious side effects, especially in those with heart conditions.
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Qualaquin (quinine sulfate): New Risk Evaluation and Mitigation Strategy - Risk of serious hematological reactions
July 14, 2010
New Risk Management Plan. Reports of serious side effects in patients using Qualaquin "off-label" for night time leg cramps.
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Cepheid Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System: Class I Recall
July 7, 2010
The firm received increasing numbers of complaints for false negative MRSA results. False negative could result in incorrect treatment or delay of care for patients with MRSA infection.
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LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors by Physio-Control Inc.: Class I Recall Due To Power Supply Failure
July 7, 2010
A power supply assembly failure can result in the inability to deliver defibrillation therapy.
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Mylotarg (gemtuzumab ozogamicin): Market Withdrawal
June 23, 2010
Magic Power Coffee: Undeclared Drug Ingredient
June 23, 2010
Product marketed as a dietary supplement for sexual enhancement contains the drug ingredient hydroxythiohomosildenafil, a chemical that may interact with prescription nitrates, and cause dangerously low blood pressure.
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Tamiflu: Counterfeit Product Sold on Internet
June 23, 2010
Potentially harmful product represented as “Generic Tamiflu”- tests revealed product does not contain oseltamivir, but cloxacillin, an antibiotic.
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Vitamin D Supplement Products: Medication Use Error
June 23, 2010
Some liquid Vitamin D supplement products are sold with droppers that could allow parents to accidentally give harmful amounts of Vitamin D to their infant.
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Benicar (olmesartan): Ongoing Safety Review
June 23, 2010
FDA evaluating data in which type 2 diabetes patients taking Benicar had a higher rate of death from cardiovascular cause compared to placebo. FDA has not concluded that Benicar increases the risk of death.
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Hospira Brand Liposyn and Propofol: Recall
June 23, 2010
Defibtech DBP-2800 Battery Packs used in Lifeline AED and ReviveR AED: Recall
June 9, 2010
AED may falsely detect an error condition during charging for a shock, then cancel charge and not provide therapy, when used with an affected battery pack.
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GammaGard Liquid, Immune Globulin Intravenous (Human)
June 9, 2010
Market withdrawal due to an increased number of adverse event reports of allergic reactions associated with two lots.
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PediaCare Children's Products [Blacksmith Brand]: Recall of four products
June 4, 2010
The four products were manufactured at a plant cited by FDA for deficiencies in Good Manufacturing Practices. Posted 05/30/2010
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Intravenous Medications Manufactured by Claris: Recall due to contamination of products
June 4, 2010
Products sold under the Claris, Sagent Pharmaceuticals, Pfizer, and West-Ward Pharmaceuticals labels. Reports of floating matter in intravenous bags of metronidazole and ondansetron. Foreign matter should not be present in a sterile injectable product.
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Arrow Brand Medicated Oil and Embrocation: Consumer Warning, Product Considered Toxic
June 4, 2010
Product contains substances which are poisonous when ingested or applied to large areas of the body.
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Hylenex recombinant (hyaluronidase human injection): Recall
June 4, 2010
Voluntary recall of all manufactured lots has been initiated as a precautionary measure due to instances of particulate matter observed in a limited number of vials during routine stability testing.
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Orlistat (marketed as Alli and Xenical): Labeling Change
June 4, 2010
Proton Pump Inhibitors (PPI): Class Labeling Change
June 4, 2010
Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen): Label Change
June 4, 2010
Risk of overdosage or suicide for patients who are addiction-prone, taking tranquilizers or antidepressant drugs.
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Metronidazole injection 500 mg / 100 ml: Voluntary recall due to non-sterility
May 24, 2010
Non-sterility of metronidazole injection administered via the intravenous route has the potential to result in infections, which could be fatal.
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GE Healthcare Aisys and Avance Anesthesia Systems: Recall
May 24, 2010
Defective control board wiring harnesses can cause the machine to unexpectedly shut down, terminating ventilation, anesthetic delivery, and potentially patient monitoring.
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Promacta (eltrombopag): Portal Venous System Thromboses in Study of Patients With Chronic Liver Disease
May 24, 2010
Study terminated following the identification of an imbalance of thrombosis of the portal venous system in patients treated with eltrombopag versus matching placebo.
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Benadryl Extra Strength Itch Stopping Gel: Packaging Changes to Reduce Use Errors
May 24, 2010
Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (Catalog Number 1570): Recall
May 7, 2010
Vivitrol (naltrexone for extended-release injectable suspension): Medication Guide Required for Patients
May 7, 2010
Baxter Colleague Infusion Pumps: FDA Ordering Recall
May 7, 2010
GnRH Agonists: Safety Review of Drug Class Used to Treat Prostate Cancer
May 7, 2010
Vita Breath Dietary Supplement
May 7, 2010
McNeil Consumer Healthcare Over-the-Counter Infants’ and Children’s Products: Recall
May 7, 2010
Certain over-the-counter Children’s and Infants’ liquid products may not meet required quality standards.
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Cardiac Science Automated External Defibrillators - Powerheart, Cardiovive, NK, Responder models: Class I Recall
May 7, 2010
UPDATED 04/27/2010. FDA’s review of updated software indicates that it detects some but not all electrical component defects. Originally posted 03/08/2010
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Covidien Initiates Voluntary Recall of Certain Shiley™ Tracheostomy Tubes
May 7, 2010
Recall due to the product’s cuff not holding air as a result of leaks in the pilot balloon inflation assembly.
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LIFEPAK 15 Monitor/Defibrillator by Physio-Control Inc.
May 7, 2010
Class I Recall issued because of the potential for the device to expectedly power off and/or power on.
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Camolyn eye drops, Fisiolin nasal drops: Voluntary recall due to non-sterility
April 13, 2010
Stud Capsule For Men: Product contains Undeclared Drug Ingredient
April 13, 2010
Product adulterated with sildenafil which may interact with nitrates to lower blood pressure to dangerous levels.
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Stalevo (entacapone/carbidopa/levodopa): Ongoing Safety Review
April 13, 2010
FDA is evaluating clinical trial data that may suggest that patients taking Stalevo may be at an increased risk for developing prostate cancer.
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MasXtreme Capsules (Natural Wellness) - product contains undeclared drug ingredient
April 13, 2010
Recall of product, sold as a dietary supplement, containing undeclared aildenafil as well as the drug phentolamine.
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Rotarix Vaccine: Update to Clinicians and Public Health Professionals
March 25, 2010
Recommendation to suspend use is a precaution while FDA learns more about the situation. No known safety risk at this time.
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Boston Scientific Implantable Cardioverter Defibrillators: Recall
March 25, 2010
Practitioners should not use these devices unless and until FDA reviews and approves changes made by the manufacturer.
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Zocor (simvastatin): increased risk of muscle injury with high doses
March 25, 2010
Ongoing review shows risk also increased when drug, especially at higher doses, is used with certain drugs.
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Becton, Dickinson (BD) Q-Syte Luer Access Split Septum Device: Class I Recall
March 25, 2010
Defective devices may result in air bubbles leaking into the infusion system and into the patient’s bloodstream.
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Gyrus ACMI Micron Bobbin Vent Tube T: Class I Recall
March 25, 2010
Device implanted for ventilation or drainage of the middle ear - shipped without being sterilized.
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Teleflex Arrow IV Tubing Sets, Accessories, and Embolectomy Catheters: Recall
March 25, 2010
Product sterility cannot be guaranteed. Testing revealed pin holes in some of the pouches in which the products are packaged.
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Plavix (clopidogrel): Reduced effectiveness in patients who are poor metabolizers of the drug
March 25, 2010
Counterfeit Polypropylene Surgical Mesh: Initial Communication
March 25, 2010
Various sizes of counterfeit flat sheets of polypropylene surgical mesh are being marketed in the United States labeled with the C. R. Bard/Davol brand name.
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Baylis Medical Torflex Transseptal Guiding Sheath: Class I Recall
March 25, 2010
Sheath tip may break off and separate during heart procedures, causing a blockage that could lead to permanent injury and/or death.
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Oral Bisphosphonates: Ongoing Safety Review of Atypical Subtrochanteric Femur Fractures
March 25, 2010
FDA review of available data have not shown a clear connection between bisphosphonate use and a risk of atypical subtrochanteric femur fractures.
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Beckman Coulter UniCel DxC Synchron Clinical System – Ion Selective Electrode Flow Cell: Class I Recall
March 25, 2010
Incorrect sodium results may be caused by build-up of protein, bacteria, and sample tube additives in the ion selective electrode flow cell.
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Abiomed AB5000 Circulatory Support System: Class I Recall
March 25, 2010
Device computer may shut down without an alarm, which can lead to serious injuries or death.
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WinRho SDF (Rho(D) Immune Globulin Intravenous (Human): Risk of Intravascular Hemolysis
March 25, 2010
Cases of intravascular hemolysis and its complications have been reported in patients treated for immune thrombocytopenic purpura with WinRho.
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Thomas Medical Products, Inc., Transseptal Sheath Introducer Kits: Class I Recall
March 9, 2010
Sheath tip may break off and separate during heart procedures, causing a blockage that could lead to permanent injury and/or death.
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Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems: Class I Recall
March 4, 2010
Reports of serious injuries and at least one death have been associated with increased Intraperitoneal Volume (IIPV), also known as overfill of the abdominal cavity.
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OneTouch SureStep Test Strips (LifeScan): Recall
March 1, 2010
Test strips are being recalled because they may provide falsely low glucose results when the glucose level is higher than 400 mg/dL.
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StatSpin Express 4 Centrifuges Model 510: Recall
February 26, 2010
Rotor may break and eject pieces of the rotor which may cause serious physical injury to bystanders and expose them to blood-borne infectious micro-organisms.
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Invirase (saquinavir): Ongoing safety review of clinical trial data
February 26, 2010
Possible association with abnormal heart rhythms when used in combination with Norvir (ritonavir).
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Avandia (rosiglitazone): Ongoing Review of Cardiovascular Safety
February 23, 2010
FDA is reviewing data from a large, long-term clinical study on possible risks for cardiovascular outcomes associated with use of rosiglitazone.
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Ear Candles: Risk of Serious Injuries
February 23, 2010
Consumers warned not to use ear candles because they can cause serious injuries, even when used according to the manufacturer’s directions.
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Long-Acting Beta-Agonists (LABAs): New Safe Use Requirements
February 23, 2010
Exjade (deferasirox): Boxed Warning
February 23, 2010
Changes to Prescribing Information re: risk of renal impairment/failure, hepatic impairment/failure or gastrointestinal hemorrhage.
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Maalox Total Relief and Maalox Liquid Products: Medication Use Errors
February 23, 2010
Consumers who have a history of gastrointestinal ulcers or a bleeding disorder should not use Maalox Total Relief because it contains bismuth subsalicylate, a substance chemically related to aspirin.
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Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp: Drug Safety Communication
February 23, 2010
FDA requires REMS that ensures that only those hospitals and healthcare professionals who have enrolled and completed training in risk management program will prescribe and dispense ESAs to patients with cancer.
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BD Q-Syte Luer Access Devices: Recall
February 23, 2010
Device may cause an air embolism or leakage of blood and/or therapy, which may result in serious injury or death.
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Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall
February 23, 2010
Tysabri (Natalizumab): Update of Healthcare Professional Information
February 23, 2010
Risk of developing progressive multifocal leukoencephalopathy (PML) increases with increasing duration of exposure to Tysabri.
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Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical
February 23, 2010
Sheath tip may break off and separate while the sheath is inside a blood vessel, leading to serious injury or death.
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Zyprexa (olanzapine): Use in Adolescents
February 23, 2010
Videx/Videx EC (didanosine): Labeling Revision - Risk of Non-Cirrhotic Portal Hypertension
February 23, 2010
Edwards Lifesciences Aquarius Hemodialysis System: Recall
February 23, 2010
Clinically significant fluid imbalance and potential for users to repeatedly override the fluid imbalance alarm.
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Velcade (bortezomib): Starting Dose Adjustments for Patients with Hepatic Impairment
February 23, 2010
Patients with moderate or severe hepatic impairment should be treated with reduced starting doses and closely monitored.
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Nipro GlucoPro Insulin Syringes: Recall
February 23, 2010
Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review
February 23, 2010
Alli 60 mg capsules (120 count refill kit): Counterfeit Product
January 19, 2010
MuscleMaster.com Products Sold on Internet as Dietary Supplements: Recall
January 19, 2010
Dietary supplements recalled due to undeclared steroids in products, posing risk of acute liver injury.
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McNeil Consumer Healthcare Over-The-Counter Products: Recall
January 19, 2010
Rapamune (sirolimus): Drug Monitoring Recommendations
January 13, 2010
Switching between assays for the same patient can produce differing results that may be clinically significant.
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Nzu, Traditional Remedy for Morning Sickness
January 13, 2010
Consumers, especially pregnant or breastfeeding women, advised to avoid product because of the potential health risks from high levels of lead and arsenic
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Tylenol Arthritis Pain Caplet, 100 count bottles: Recall of all lots
January 13, 2010
Recall expanded from November recall of 5 lots due to reports of moldy, musty, or mildew-like odor that was associated with nausea, stomach pain, vomiting and diarrhea. Posted 12/28/2009
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Thermoflect Blankets and product line - Recall
January 13, 2010
FDA recommends blankets and other products not be used in magnetic resonance [MR] conditional or MR compatible environments
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Steris System 1 Processor: FDA Notice and Recommendations
January 13, 2010
[UPDATED 12/17/2009] List of alternative products added. Unapproved device with potential for improper sterilization and disinfection.
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Cleviprex (clevidipine butyrate): Recall
January 13, 2010
Presence of particulate matter which could potentially reduce blood flow in capillaries, cause mechanical damage to some tissues, or initiate acute or chronic inflammatory reactions.
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Atlas Operations, Inc.: Recall of Sexual Enhancement Products
January 13, 2010
Recall of products, sold as a dietary supplements, containing undeclared sulfoaildenafil, which may result in lowering of blood pressure to dangerous levels.
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Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels - Incorrect Packaging
January 13, 2010
One lot recalled because labeling on the foil blister card of certain packages were printed with the label reversed, and consumers may not be aware of the warnings of an antihistamine that could cause drowsiness.
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Voltaren Gel (diclofenac sodium topical gel) 1% - Hepatic Effects Labeling Changes
January 13, 2010
Cases of drug-induced hepatotoxicity reported, including liver necrosis, jaundice, fulminant hepatitis with and without jaundice, and liver failure.
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Valproate Sodium and related products (valproic acid and divalproex sodium): Risk of Birth Defects
January 13, 2010
Increased risk of neural tube defects and other major birth defects, such as craniofacial defects and cardiovascular malformations, in babies exposed to valproate sodium and related products during pregnancy.
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Lexiva (fosamprenavir calcium) - Dear Healthcare Professional Letter
January 13, 2010
Norpramin (desipramine hydrochloride) - Dear Healthcare Professional Letter
January 13, 2010
Stryker Operating Room System II Surgical Navigation System - Recall
November 30, 2009
A potential for the navigation PC SPC-1 component to stop working which could result in potential harms associated with this failure.
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Meridia (sibutramine hydrochloride): Early Communication about an Ongoing Safety Review
November 30, 2009
FDA is reviewing preliminary data from a recent study suggesting that patients using sibutramine have a higher number of cardiovascular events (heart attack, stroke, resuscitated cardiac arrest, or death) than patients using a placebo.
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Cardiac Science Corp. Powerheart and CardioVive Automated External Defibrillators: Initial Communication
November 30, 2009
Defective components may cause affected devices to not deliver electric shocks, and the device's self-test may not detect the defect in advance of use.
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Vicks Sinex Nasal Spray - Recall
November 30, 2009
RockHard Weekend - product contains undeclared drug ingredient
November 30, 2009
Cardiovascular Systems ViperSheath Sheath Introducer - Recall
November 30, 2009
IDS Sports Dietary Supplements - Recall
November 30, 2009
Five products marketed as dietary supplements contain undeclared substances considered to be steroids.
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Clopidogrel (marketed as Plavix) and Omeprazole (marketed as Prilosec) - Drug Interaction
November 30, 2009
Effectiveness of clopidogrel is reduced when taken with omeprazole, placing patients who use clopidogrel to prevent blood clots at risk for heart attacks or strokes if they are also taking omeprazole.
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Negative Pressure Wound Therapy (NPWT) systems - Public Health Notification
November 16, 2009
Reports of deaths and serious complications, especially bleeding and infection, associated with NPWT.
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Pai You Guo, Marketed as Dietary Supplement - Recall
November 16, 2009
Local Anesthetics, Continuously Infused (marketed as bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine, ropivacaine) - Chondrolysis
November 16, 2009
Reports of chondrolysis in patients given continuous intra-articular infusions of local anesthetics with elastomeric infusion devices.
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Genzyme Products, Marketed as Cerezyme, Fabrayzme, Myozyme, Aldurazyme, and Thyrogen
November 16, 2009
Foreign particle contamination of several products manufactured by Genzyme, which may lead to serious adverse events including damage to blood vessels or embolic events, and anaphylactic, allergic and immune-mediated reactions.
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External Biphasic Defibrillators Energy Levels: Initial Communication
November 16, 2009
14 events reported in which a 200 J biphasic defibrillator was ineffective in providing fibrillation / cardioversion therapy to a patient.
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Hospira Brand Propofol and Liposyn Products - Recall
November 16, 2009
Product containers may contain particulate matter that could act as emboli and lead to impeded blood flow.
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Stiff Nights - product contains undeclared drug ingredient
November 16, 2009
Ketorolac Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials -- Recall
November 5, 2009
Nationwide recall due to the potential for particulate matter in conjunction with crystallization in the product.
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Bodybuilding.com Brand Dietary Supplements - Sold on Internet
November 5, 2009
Dietary supplements recalled due to undeclared steroids in products with risk of acute liver injury.
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Byetta (exenatide) - Renal Failure
November 5, 2009
Cases of altered kidney function, including acute renal failure and renal insufficiency, in patients using Byetta.
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Pointe Scientific Liquid Glucose Hexokinase Reagent - Recall
November 5, 2009
Nationwide recall of all size kits. The reagents have been found to fail linearity at >200mg/dL that results in inaccurate glucose values above this range.
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Cordis CROSSOVER Sheath Introducer - Recall
November 5, 2009
Accusure Insulin Syringes (Qualitest Pharmaceuticals) - Recall
November 5, 2009
Nationwide recall of all lots of product due to potential for needle to become detached from syringe during use.
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Peramivir IV
November 5, 2009
Investigational antiviral drug approved for emergency use in H1N1 influenza infection; mandatory reporting of adverse events required by healthcare providers.
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Rituxan (rituximab) - PML
November 5, 2009
Third case of PML reported, the first case of PML in a patient with rheumatoid arthritis treated with Rituxan who has not previously received treatment with a TNF antagonist.
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Medical Device Power Cords Safety Investigation: Initial Communication
November 5, 2009
Dexferrum (iron dextran injection) - labeling change
October 16, 2009
Risk of anaphylactic-type reactions, including fatalities, have followed the parenteral administration of iron dextran injection.
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Relenza (zanamivir) Inhalation Powder
October 13, 2009
Drug must not be reconstituted in liquid formulation or used in any nebulizer or mechanical ventilator.
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CT Brain Perfusion Scans Safety Investigation: Initial Notification
October 13, 2009
Unomedical Manual Pulmonary Resuscitator - Recall
October 13, 2009
Recall due to malfunction which impairs ability of device to generate positive pressure necessary to function properly.
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Philips Heartstart Fr2+ Automated External Defibrillators - Recall
October 7, 2009
Nationwide recall due to reports of a memory chip failure which could render the AED inoperable and prevent it from delivering therapy when indicated.
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Neuron 6F 070 Delivery Catheter [Penumbra]
October 7, 2009
Field removal of the catheter due to reports that the catheter could kink or ovalize in certain anatomical situations, lead to difficulty in catheter advancement and/or delivery of other devices through the guide catheter
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Heparin: Change in Reference Standard
October 7, 2009
The change will result in 10% reduction in the potency of the heparin marketed in the U.S. and may have clinical significance in some situations, such as when heparin is administered as a bolus intravenous dose and an immediate anticoagulant effect is clinically important
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Neocate Infant Specialized Formula - Recall
October 7, 2009
Nationwide recall of Neocate Infant Specialized Formula, Lot # P91877, due to a manufacturing error that resulted in protein levels lower than that declared on the label.
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Children's and Infants' Tylenol Oral Suspension Products - Recall
October 7, 2009
Exjade (deferasirox) - Early Communication
October 7, 2009
Early Communication describing an increased number of adverse events and deaths in patients using Exjade who are over sixty years old who have myelodysplastic syndrome (MDS).
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Sitagliptin (marketed as Januvia and Janumet) - acute pancreatitis
October 7, 2009
Tamiflu (oseltamivir) for Oral Suspension: Potential Medication Errors
October 7, 2009
Pharmacists and pediatrics healthcare profesionals notified of risk of medication dosing errors
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Medtronic Neuromodulation, INDURA 1P Intrathecal Catheter, Intrathecal Catheter, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit
October 7, 2009
Class I Recall due to possibility of obstruction or disruption of therapy. Posted 09/24/2009
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Portex Uncuffed Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0 and 3.5 mm)
October 7, 2009
Natalizumab (marketed as Tysabri)
October 7, 2009
FDA continues to receive reports of progressive multifocal leukoencephalopathy (PML) in patients receiving Tysabri.
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Promethazine Hydrochloride Injection
October 7, 2009
Boxed Warning added to labeling, describing risks of severe tissue injury, including gangrene, following intravenous administration of promethazine.
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Covidien Pedi-Cap End-Tidal CO2 Detector
October 7, 2009
Class I recall because the device may increase the resistance of the flow of air into the lungs, resulting in ineffective ventilation and the inability to verify the correct placement of a breathing tube when inserting it into the windpipe.
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ConMed Linvatec - Universal Cables and Power Pro Handpieces
October 7, 2009
Class 1 recall due to risk of powered device self-activation and injury to patient or surgical staff.
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Albuterol Sulfate Inhalation Solution unit-dose vials (Dey LP brand)
October 7, 2009
Two lots (35,760 cartons) stolen in Texas. Pharmacies encouraged to verify pedigree documentation for all purchases of Dey-labeled Albuterol.
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Penumbra Neuron 5F Select Catheter
October 7, 2009
Class 1 recall due to defect which may result in brain blood clot and blood vessel puncture.
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Philips Avalon Fetal Monitors
October 7, 2009
Safety alert issued due to complaints of inaccurate output readings that may lead to failure to identify fetal distress.
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Myfortic (mycophenolic acid)
October 7, 2009
Hospira, Inc. Device Recall
August 18, 2009
Potential risks from Hospira, Inc. power cord failure include electrical shock, delay in setup and therapy, interruption of therapy, device failure, and fires.
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Dextroamphetamine, Amphetamine 20mg Tablets
August 14, 2009
Recalled because the affected lot may contain some tablets exceeding weight requirements which may lead to super-potent tablets.
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CellCept (mycophenolate mofetil) August 2009
August 14, 2009
GDH-PQQ (glucose dehydrogenase pyrroloquinoline quinone) Glucose Monitoring Technology
August 14, 2009
GDH-PQQ Glucose Monitoring Technology - possibility of falsely elevated blood glucose results when using GDH-PQQ (glucose dehydrogenase pyrroloquinoline quinone) glucose test strips, which may mask significant hypoglycemia or prompt excessive insulin administration, leading to serious injury or death.
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Alaris System (Cardinal Health)
August 14, 2009
Class 1 recall due to potential for patients experiencing under- or over-infusion, which may result in serious injury or death.
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Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi) August 2009
August 14, 2009
FDA notified healthcare professionals of an update to the Boxed Warning describing an increased risk of lymphoma and other malignancies in children and adolescents treated with TNF blockers.
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POWERSAIL Coronary Dilatation Catheters
August 14, 2009
Class 1 recall due to damage to distal catheter shaft and risk of air embolism and myocardial infarction.
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Colchicine (marketed as Colcrys)
August 14, 2009
Steam Dietary Supplement
July 30, 2009
Product recalled because samples were found to contain an undeclared drug ingredient, an analog of sildenafil.
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Body Building Products (Marketed as Containing Steroids or Steroid-like Substances)
July 30, 2009
Electronic Cigarettes
July 30, 2009
FDA analysis has found carcinogens and toxic chemicals such as diethylene glycol, an ingredient used in antifreeze.
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Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 [Dräeger/Hill-Rom]
July 30, 2009
Nuby Gel Filled, Cottontails, and Playschool Teethers
July 21, 2009
Nationwide recall due to potential bacterial contamination, placing children with weakened immune systems at risk of harm.
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Propofol Injectable Emulsion, 10 mg/mL 100 mL vials
July 21, 2009
Weight Loss Products by Young You Corporation
July 21, 2009
Products recalled due to an undeclared drug ingredient which may present a significant health risk for patients with history of coronary artery disease, congestive heart failure, arrhythmias or stroke. Posted 07/17/2009
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Omalizumab (marketed as Xolair) - Early Communication about an Ongoing Safety Review
July 21, 2009
FDA is evaluating interim safety findings from an ongoing study of Xolair (omalizumab) that suggests an increased number of cardiovascular and cerebrovascular adverse events.
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Nature & Health Co. supplement products: LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid and Capsule, Herbal Disiac
July 16, 2009
Concentrated Acetaminophen Drops
July 16, 2009
Nationwide voluntary recall of all lots of Brookstone Pharmaceuticals' Concentrated Acetaminophen Drops in 16 ounce (473 ml) bulk containers, a cautionary measure to minimize any confusion and potential risk to patients from dosing errors.
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Libipower Plus
July 15, 2009
Product recalled because samples were found to contain undeclared Tadalalafil, an active ingredient of FDA approved drugs for Erectile Dysfunction. Tadalalafil may interact with nitrates found in some prescription drugs such as nitroglycerin, and may lower blood pressure to dangerous levels.
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Immunosuppressant Drugs: Required Labeling Changes
July 15, 2009
FDA requiring manufacturers of immunosuppressant drugs to update their prescribing information to include stronger warnings about the risk of BK virus-associated nephropathy.
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Medtronic Paradigm Quick-Set Infusion Sets
July 15, 2009
Nationwide recall because the affected infusion sets may not allow the insulin pump to vent air pressure properly, resulting in the device delivering too much or too little insulin, potentially leading to serious injury or death.
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Mallinckrodt Sodium Chromate Cr-51 Injection
July 10, 2009
BiPAP Focus Non-Invasive Ventilator System, Respironics California
July 10, 2009
Stealth Chocolate, Stealth Vanilla Powdered Dietary Supplement: Vital Pharmaceuticals Inc
July 10, 2009
Arthroscopic Shavers: Ongoing Safety Review
July 8, 2009
Reports submitted to FDA describing instances of tissue remaining within certain arthroscopic shavers, even after the cleaning process was believed to have been completed.
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Propoxyphene-containing Products
July 8, 2009
FDA taking actions to reduce the risk of overdose in patients using pain medications that contain propoxyphene because of data linking propoxyphene and fatal overdoses.
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Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics)
July 8, 2009
FDA requires new Boxed Warnings and patient Medication Guides highlighting the risk of serious neuropsychiatric symptoms
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Lantus (insulin glargine)
July 8, 2009
Nestle Toll House Prepackaged, Refrigerated Cookie Dough
June 25, 2009
FDA and the CDC are warning consumers not to eat any varieties of prepackaged Nestle Toll House refrigerated cookie dough due to the risk of contamination with E. coli O157:H7 (a bacterium that causes food borne illness). Since March 2009 there have been 66 reports of illness across 28 states. Twenty-five persons were hospitalized; 7 with a severe complication called Hemolytic Uremic Syndrome. No one has died.E. coli O157:H7 causes abdominal cramping, vomiting and a diarrheal illness, often with bloody stools. Most healthy adults can recover completely within a week. Young children and the elderly are at highest risk for developing HUS,which can lead to serious kidney damage and even death.
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Stamina-Rx Dietary Supplement Products
June 25, 2009
FDA and Hi-Tech Pharmaceuticals notified patients and healthcare professionals of a nationwide recall of all product sold under the name Stamina-Rx. Hi-Tech was notified by the FDA that the lab analysis of Stamina-Rx samples found that the product contained the undeclared ingredient - benzamidenafil - a Phosphodiesterase Type 5 inhibitor. Posted 06/19/2009
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Cefepime (marketed as Maxipime) Update of Ongoing Safety Review
June 25, 2009
FDA finished its analysis of a possible risk of higher death with cefepime and has determined that the data do not indicate a higher rate of death in cefepime-treated patients.
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Zicam Cold Remedy Nasal Products (Cold Remedy Nasal Gel, Cold Remedy Nasal Swabs, and Cold Remedy Swabs, Kids Size)
June 25, 2009
FDA notified consumers and healthcare professionals to discontinue use of three Zicam Nasal Gel/Nasal Swab products sold over-the-counter as cold remedies because they are associated with the loss of sense of smell, that may be long-lasting or permanent. The FDA has received more than 130 reports of loss of sense of smell associated with the use of these three Zicam products. In these reports, many people who experienced a loss of smell said the condition occurred with the first dose; others reported a loss of the sense of smell after multiple uses of the products
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Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder - Communication about an Ongoing Safety Review
June 25, 2009
FDA provides its perspective on study data published in the American Journal of Psychiatry on the potential risks of stimulant medications used to treat Attention-Deficit/Hyperactivity Disorder in children. The study authors concluded that there may be an association between the use of stimulant medications and sudden death in healthy children.
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Levemir Insulin (Novo Nordisk)
June 25, 2009
Patients advised to check personal supply of insulin to identify possible stolen and dangerous product.
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Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR)
June 25, 2009
FDA provided healthcare professionals with updated information on the original March 2008 early communication and January 2009 follow-up communcation about the ongoing safety review for the Leukotriene inhibitors, montelukast, zafirlukast and zileuton. Neuropsychiatric events have been reported in some patients taking montelukast (Singulair), zafirlukast (Accolate), and zileuton (Zyflo and Zyflo CR). FDA has requested that manufacturers include a precaution in the drug prescribing information (drug labeling). The reported neuropsychiatric events include postmarket cases of agitation, aggression, anxiousness, dream abnormalities and hallucinations, depression, insomnia, irritability, restlessness, suicidal thinking and behavior (including suicide), and tremor.
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Medtronic Kappa Series 600/700/900, Sigma Series 100/200/300 Pacemakers
June 25, 2009
Class I recall of certain Kappa and Sigma Series pacemakers, because these devices may fail due to a separation of wires that connect the electronic circuit to other pacemaker components.
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Sirolimus (marketed as Rapamune)
June 11, 2009
FDA notified healthcare professionals of clinical trial data that suggest increased mortality in stable liver transplant patients after conversion from a calcineurin inhibitor (CNI)-based immunosuppressive regimen to sirolimus (Rapamune). The trial was conducted by sirolimus manufacturer, Wyeth. The Agency will continue to examine the data on mortality and other adverse events in this study, and will make further recommendations, as appropriate. The FDA is determining whether a labeling change for sirolimus is needed. In the interim, physicians should continue to use the drug’s professional labeling as a guide to therapy. See the FDA Healthcare Professional Information sheet for current FDA recommendations.
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Skin Products Made by Clarcon
June 9, 2009
FDA notified consumers and healthcare professionals that Clarcon Biological Chemistry Laboratory is recalling some skin sanitizers and skin protectants because of high levels of disease-causing bacteria found in the product. During an FDA inspection, analyses of samples of several of these products revealed high levels of various bacteria, including some associated with unsanitary conditions. Some of these bacteria can cause opportunistic infections of the skin and underlying tissues. Such infections may need medical or surgical attention, and may result in permanent damage. These findings are particularly concerning because the products are promoted as antimicrobial agents that claim to treat open wounds, damaged skin, and protect against various infectious diseases. FDA is warning consumers to not use any Clarcon products and should throw these products away in household refuse.
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Propylthiouracil
June 9, 2009
January 2009
June 9, 2009
Simponi (golimumab)
June 9, 2009
Risk of serious fungal infections associated with TNF-a blockers, including Simponi (golimumab). Posted 05/28/2009
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November 2008
June 9, 2009
October 2008
June 9, 2009
Testosterone gel products (AndroGel 1% and Testim 1% )
June 9, 2009
Boxed warning required to inform users of risk of unintended secondary exposure of children to testosterone.
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Fun Express Water-based Face Paints for Children
June 9, 2009
UPDATE - Fun Express expanded its recall of face paint items to include two additional face paint colors, 85/2338 (White face paint) and 85/2339 (Yellow face paint)
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Biosite brand Triage Cardiac Panel
June 9, 2009
Use of affected lots of the Triage Cardiac Panel may lead to false negative results, possibly resulting in missed or incorrect diagnosis.
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Tarceva (erlotinib) May 2009
June 9, 2009
Dear Healthcare Professional letter issued to warn about GI perforation, exfoliative skin conditions and corneal perforation/ulceration.
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Tri-State Hospital Supply Corporation, Centurion Brand Trays and Kits
June 9, 2009
Ceftriaxone (marketed as Rocephin and generics)
June 9, 2009
Influend Cough and Cold Products
June 9, 2009
Digoxin, USP 0.125 mg, Digoxin, USP 0.25 mg (Caraco brand)
April 1, 2009
Recall of tablets because they may differ in size and therefore could have more or less of the active ingredient.
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Medtronic Neurologic Technologies, Innervision Snap Shunt Ventricular Catheter, BioGlide and Snap Shunt Ventricular Catheter, BioGlide
April 1, 2009
Class I recall due to the possibility that the ventricular catheter may become detached from the snap base assembly after implantation and may require emergency corrective surgery.
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Propafenone HCL Tablets
April 1, 2009
February 2009 Safety Labeling Changes
March 24, 2009
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides.
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Weight Loss Products
March 24, 2009
UPDATE - FDA expanded its nationwide alert to consumers about tainted weight loss products containing undeclared, active pharmaceutical ingredients.
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Zencore Plus
March 24, 2009
Nationwide recall of supplement, found to contain an undeclared drug, which may cause life-threatening risk of sudden drop in blood pressure.
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Insulin Pens: Risk of Transmission of Blood-borne Pathogens from Shared Use
March 24, 2009
Sharing of insulin pens may result in transmission of hepatitis viruses, HIV, or other blood-borne pathogens.
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Welch Allyn AED 10 and MRL JumpStart Defibrillators
March 24, 2009
Devices may experience low energy shock, unexpected device shutdown, and/or susceptibility to electromagnetic noise interference, preventing defibrillation of a patient in cardiac arrest.
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Colleague Single and Triple Channel Volumetric Infusion Pumps by Baxter
March 24, 2009
Class 1 Recall issued because software and battery usage failures were identified that result in a delay in or interruption of infusion that may cause serious injury and/or death.
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Shiley 3.0PED Cuffless Pediatric Tracheostomy Tube by Covidien Inc.
March 12, 2009
Class 1 Recall due to complaints received about difficulty inserting the device used to place the tracheostomy tube into the windpipe (obturator), and/or a suction tube (catheter) into the tracheostomy tube.
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January 2009 Safety Labeling Changes
March 12, 2009
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides.
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Transdermal Drug Patches with Metallic Backings: Risk of Burns during MRI Scans
March 12, 2009
Metoclopramide-Containing Drugs
March 2, 2009
Chronic use of metoclopramide has been linked to tardive dyskinesia, which may include involuntary and repetitive movements of the body, even after the drugs are no longer taken.
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Zonisamide (marketed as Zonegran, and generics)
March 2, 2009
Raptiva (efalizumab)
March 2, 2009
Public Health Advisory describes rare brain condition, progressive multifocal leukoencephalopathy, associated with the use of Raptiva.
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December 2008 Safety Labeling Changes
March 2, 2009
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides.
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CellCept (mycophenolate mofetil)
February 13, 2009
Medication Guide issued, providing important safety information, to be distributed to every patient who fills a CellCept prescription from this point forward.
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Ethex Corporation Product Recall
February 13, 2009
UPDATE - Nationwide recall expanded to include various prescription prenatal vitamin and iron supplement products.
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Xigris (Drotrecogin alfa (activated)) - Early Communication about an Ongoing Safety Review
February 13, 2009
FDA is evaluating a study showing increased incidence of serious bleeding events and mortality in patients who received Xigris.
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November 2008 Safety Related Labeling Changes
February 13, 2009
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides.
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Venom HYPERDRIVE 3.0
February 13, 2009
Product marketed as dietary supplement contains undeclared sibutramine, a controlled substance with risks for abuse or addiction, and can substantially increase blood pressure and heart rate.
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Clopidogrel bisulfate (marketed as Plavix)
February 13, 2009
FDA to conduct safety review to evaluate differences in efffectiveness, genetic factors, potential drug interactions.
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Topical Anesthetics
February 13, 2009
Patients, healthcare professionals, and caregivers alerted to serious hazards of using skin numbing products for relieving pain from mammography and other medical tests and conditions, especially when applied to a large area of skin or when the area of application is covered.
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Innohep (tinzaparin sodium injection)
December 4, 2008
Clinical study stopped early because of interim finding of increase in all-cause mortality in patients who received Innohep.
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Starcaps Dietary Supplement Capsules
December 4, 2008
Recall due to undeclared drug, Bumetanide, resulting in drug interactions including risk of hypotension (low blood pressure), or fainting (syncope).
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Zhen De Shou Fat Loss Capsules
December 4, 2008
Recall due to undeclared sibutramine, an appetite suppressant known to substantially increase blood pressure and/or pulse rate in some patients.
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Phenytoin (marketed as Dilantin, Phenytek and generics) and Fosphenytoin Sodium (marketed as Cerebyx and generics)
December 4, 2008
Potential increased risk of serious skin reactions, including Stevens Johnson syndrome and toxic epidermal necrolysis, from phenytoin therapy in Asian patients positive for a particular human leukocyte antigen allele, HLA-B*1502.
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Animas Corporation Battery Caps Used with the OneTouch Ping System, Animas 2020 Insulin Pump, Animas IR1200 Insulin Pump, and Animas IR1250 Insulin Pump
November 21, 2008
Potential for device to stop administering insulin, resulting in hyperglycemia or hypoglycemia.
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Benzoyl Peroxide Acne Cream 10% marked as: DG Maximum Strength Acne Medicated Gel; Kroger Acne Gel 10% Benzoyl Peroxide Acne Medication; Equate: Medicated Acne Gel
November 20, 2008
ReliOn Insulin Syringes for use with U-100 Insulin (Tyco Healthcare - Covidien)
November 6, 2008
September 2008 Safety-Related Labeling Changes
November 6, 2008
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides.
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Vibe Technologies Vibrational Integrated Bio-photonic Energizer Machine Multi-Frequency Field Generator
November 6, 2008
Thoratec HeartMate II Left Ventricular Assist System
November 6, 2008
Device correction because the wear and fatigue of the percutaneous lead connecting the blood pump with the system controller may cause serious injury or death.
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Transvaginal Placement of Surgical Mesh
October 27, 2008
Serious complications associated with transvaginal placement of surgical mesh in repair of pelvic organ prolapse and stress urinary incontinence.
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Raptiva (efalizumab)
October 21, 2008
Dextroamphetamine Sulfate 5mg Tablets
October 21, 2008
Drug recall due to the potential for oversized tablets that may be associated with an increased risk of adverse effects.
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Over The Counter Cough and Cold Medications
October 21, 2008
Nebion HLX-8 Magnetic Resonance Device
October 6, 2008
Device recalled because it was not approved by FDA, lacked safety and effectiveness data, and was not manufactured under current good manufacturing practices.
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Medtronic Neuromodulation INDURA One-Piece Intrathecal Catheters, Sutureless Pump Connector Revision Kit, Intrathecal Catheter Pump Segment Revision Kit
October 6, 2008
Class I Recall because of potential misconnections of the Medtronic sutureless connector catheters from the catheter port on the pump.
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Statin drugs and amyotrophic lateral sclerosis (ALS)
October 1, 2008
New analysis of 41 long-term controlled clinical trials provides evidence that use of statins does not increase incidence of ALS.
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Epoetin alfa
September 29, 2008
Preliminary safety findings from a German clinical trial showed more deaths in patients given epoetin-alpha versus placebo.
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Ammonul (sodium phenylacetate and sodium benzoate) Injection 10%/10%
September 24, 2008
Particulate matter detected in product. Healthcare providers instructed to use a filter during the admixture process.
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Tarceva (erlotinib)
September 24, 2008
Cases of hepatic failure and hepatorenal syndrome, including fatalities, have been reported during use of Tarceva, particularly in patients with baseline hepatic impairment.
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Phosphocol P 32 (Chromic Phosphate P 32 Suspension)
September 22, 2008
August 2008 Safety-Related Labeling Changes
September 17, 2008
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of drug Prescribing Information, plus Patient Package Inserts and Medication Guides.
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Infant Formula Manufactured in China
September 15, 2008
LifePak CR Plus Automated External Defibrillators
September 15, 2008
Class I Recall because the shock button is not visible, making the responder unable to provide shock therapy.
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Rituxan (rituximab)
September 15, 2008
Progressive Multifocal Leukoencephalopathy with use of Rituxan in patient with rheumatoid arthritis.
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Disposable Battery Operated Lavage System (BOLS)
September 10, 2008
The cutting of battery pack cables for disposal can lead to sparks, fires, toxic fumes, and explosions.
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Tumor necrosis factor-a blockers (TNF blockers), Cimzia (certolizumab pegol), Enbrel (etanercept), Humira (adalimumab), and Remicade (infliximab)
September 10, 2008
Opportunistic infections are not consistently recognized in patients taking tumor necrosis factor-a blockers.
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Pacific Consolidated brand Mobile Oxygen Storage Tank
September 10, 2008
Class I Recall because the device's pressure gauge may rupture and may catch fire as a result of hydraulic fluid present in the pressure gauge tubing.
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Tysabri (natalizumab)
August 26, 2008
Two new cases of progressive multifocal leukoencephalopathy in European patients receiving Tysabri as monotherapy for multiple sclerosis for more than one year.
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Ezetimibe/Simvastatin (Vytorin); Simvastatin (Zocor); and Ezetimibe (Zetia)
August 26, 2008
Report of SEAS trial of a possible association between the use of Vytorin and a potential increased incidence of cancer.
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July 2008 Monthly Safety Labeling
August 26, 2008
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides.
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Boston Scientific NexStent Monorail, NexStent Carotid Stent and Monorail Delivery System
August 26, 2008
Product recalled because the tip of the stent delivery system may detach during a carotid artery stenting procedure.
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Vivitrol (naltrexone)
August 12, 2008
Simvastatin Used With Amiodarone
August 12, 2008
Risk of rhabdomyolysis when simvastatin is used with amiodarone, particularly with simvastatin doses greater than 20 mg daily.
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Levitronix CentriMag Extracorporeal Blood Pumping System: CentriMag Primary Console (with v200 Application Software)
August 7, 2008
Physicians warned not to use Blood Pumping System with Valleylab Force FX-C or SSE2L electrosurgery devices because use may result in stoppage of the pump and may cause serious injury or death.
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Viapro 375mg Capsules
August 1, 2008
Product recalled because it was found to contain a potentially harmful analog of Sildenafil.
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Erythropoiesis Stimulating Agents (ESAs) - Epoetin alfa (marketed as Procrit, Epogen), Darbepoetin alfa (marketed as Aranesp)
August 1, 2008
FDA clarifies approved conditions for use of ESAs in patients with cancer and revises dosing directions for the products.
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June 2008 Monthly Safety Labeling
July 31, 2008
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides.
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Mitoxantrone Hydrochloride (marketed as Novantrone and generics)
July 31, 2008
Post-marketing safety study shows poor adherence to cardiac monitoring recommendations in clinical practice. FDA is working with the manufacturers to educate healthcare providers to adhere to recommendations for patients with MS.
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Micro-bubble Contrast Agents (marketed as Definity (Perflutren Lipid Microsphere) Injectable Suspension and Optison (Perflutren Protein-Type A Microspheres for Injection)
July 18, 2008
Changes to the Boxed Warning, Warnings, and Contraindications sections of the prescribing information to reflect conclusions of FDA reviews of information received following the addition of new contraindications and warnings in October 2007.
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Electronic Medical Devices
July 18, 2008
Possible malfunction of Electronic Medical Devices caused by Computed Tomography (CT) Scanning on patients with implanted and external electronic medical devices.
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Sodium Polystyrene Sulfonate Suspension
July 18, 2008
Recall of 2 lots of the product due to the presence of yeast which could affect patients who are immunocompromised.
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Avastin (bevacizumab)
July 16, 2008
Reports of microangiopathic hemolytic anemia in patients treated with this unapproved combination.
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May 2008 Monthly Safety Labeling
July 10, 2008
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides.
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Herceptin 440 mg Vials and BWFI Diluent
July 10, 2008
Complaints of damaged and broken vials of Herceptin 440 mg and BWFI diluent that may lead to a loss of sterility, which may cause infections in patients.
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Fluoroquinolone Antimicrobial Drugs
July 10, 2008
BOXED WARNING and Medication Guide to be added to prescribing information to strengthen existing warnings about the increased risk of developing tendinitis and tendon rupture in patients taking fluoroquinolones for systemic use.
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Rize 2 The Occasion Capsules and Rose 4 Her Capsules
July 7, 2008
Certain lots of both products were recalled because they contained an undeclared ingredient.
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Recombinant Human Bone Morphogenetic Protein in Cervical Spine Fusion
July 7, 2008
Reports of life-threatening complications associated with recombinant human Bone Morphogenetic Protein when used in the cervical spine.
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April 2008 Monthly Safety Labeling
July 7, 2008
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides.
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March 2008 Monthly Safety Labeling
July 7, 2008
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides.
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2% Chlorhexidine Gluconate Cloth Patient Preoperative Skin Preparation Product
July 7, 2008
February 2008 Monthly Safety Labeling
July 7, 2008
Summary of safety-related revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, and ADVERSE REACTIONS sections of the Prescribing Information, plus Patient Package Inserts and Medication Guides.
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Antipsychotics, Conventional and Atypical
June 19, 2008
New studies show an increased risk of mortality in elderly patients treated for dementia-related psychosis with conventional antipsychotic drugs.
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Morphine Sulfate 60 mg Extended Release Tablets
June 11, 2008
Voluntarily recall of a single lot (No. 91762) due to a report of a tablet with twice the appropriate thickness.
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Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, and Cimzia)
June 5, 2008
Calcilo XD Low-Calcium Vitamin D-Free Infant Formula With Iron Powder
June 5, 2008
Product recalled because of possible oxidation that can cause gastrointestinal symptoms in infants.
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Viril-ity Power (VIP) Tablets
June 5, 2008
Product recalled because it contains a potentially harmful, undeclared ingredient that may interact with nitrates found in some prescription drugs and can lower blood pressure to life-threatening levels.
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Mommy's Bliss Nipple Cream
May 29, 2008
Product contains potentially harmful ingredients that may cause respiratory distress or vomiting and diarrhea in infants.
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Xiadafil VIP Tablets
May 28, 2008
Consumers advised not to purchase or use the product, marketed as a dietary supplement, because it contains a potentially harmful, undeclared ingredient that may dangerously affect a person's blood pressure and can cause other life-threatening side effects.
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Solodyn (minocycline HCL) Extended Release Tablets 90 mg
May 20, 2008
Mycophenolate Mofetil (marketed as CellCept) and Mycophenolic Acid (marketed as Myfortic)
May 19, 2008
FDA issues an FDA Alert and Information for Healthcare Professional sheet for Mycophenolate Mofetil (MMF) and Mycophenolic Acid (MPA).
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Cardinal Alcohol-Free Mouthwash
May 15, 2008
Enbrel (etanercept)
May 2, 2008
Prescribing information revised to include a BOXED WARNING regarding the risk of infection including tuberculosis.
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Digitek (digoxin tablets, USP)
April 29, 2008
January 2008 Safety Labeling
April 25, 2008
Changes to the BOXED WARNING, WARNINGS, CONTRAINDICATIONS, PRECAUTIONS, and ADVERSE REACTIONS sections of the labels, plus Medication Guides and Patient Package Inserts.
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Parenteral Maltose/Parenteral Galactose/Oral Xylose-Containing Products
April 25, 2008
UPDATE -- Fatal Iatrogenic Hypoglycemia -- Life threatening falsely elevated blood glucose readings with a point-of-care meter due to a maltose-containing intravenous immune globulin product. Final report of an investigation issued.
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Herbal Science International, Inc. Dietary Herbal Supplements
April 14, 2008
Twelve dietary herbal supplements recalled because they contain ephedra, aristolochic acid or human placenta and may present a serious health hazard to consumers.
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Exubera (insulin human rDNA origin) Inhalation Powder
April 11, 2008
WARNINGS section of prescribing information updated to include information about 6 newly diagnosed cases of primary lung malignancies in clinical trials.
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Cubicin (daptomycin for injection)
April 11, 2008
Potentially significant impurity isolated from reconstituted product stored in ReadyMED pumps.
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CellCept (mycophenolate mofetil), Myfortic (mycophenolate acid)
April 11, 2008
Possible association between the use of these products and the development of progressive multifocal leukoencephalopathy.
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Neupro (rotigotine transdermal system)
April 11, 2008
Product recalled due to formation of rotigotine crystals in the patches which may affect the efficacy of the product.
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Heparin Sodium USP Pre-Filled Syringes
April 3, 2008
Voluntary nationwide recall issued by Covidien because two lots of the product contained a heparin-like contaminant.
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Relenza (zanamivir)
April 3, 2008
Changes to the WARNINGS AND PRECAUTIONS Sections of Prescribing Information for Relenza about postmarketing reports of neurologic and behavioral symptoms.
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Total Body Formula, Total Body Mega Formula
April 2, 2008
Recall of liquid dietary supplement products, after reports of severe adverse reactions, including significant hair loss, muscle cramps, diarrhea, joint pain and fatigue.
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Ziagen (abacavir) and Videx (didanosine)
April 2, 2008
Data analyses from the Data Collection on Adverse Events of Anti-HIV Drugs Study indicates a higher risk of heart attack in patients infected with HIV-1 who were taking Ziagen or Videx.
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Regranex (becaplermin) Gel
April 2, 2008
Study data suggests possible increased risk of death from cancer in diabetic patients using Regranex Gel.
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Singulair (montelukast)
April 2, 2008
Possible association between the use of Singulair and behavior/mood changes, suicidality, and suicide.
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"Blue Steel" and "Hero" Dietary Supplement Products
April 2, 2008
Products promoted for the treatment of erectile dysfunction and for sexual enhancement contain undeclared ingredients which may interact with nitrates found in some prescription drugs, and can lower blood pressure to dangerous levels.
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December 2007 Monthly Safety Labeling
March 25, 2008
Revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS labeling sections, and Patient Package Inserts or Medication Guides.
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B. Braun Heparin Sodium in 5% Dextrose and 0.9% Sodium Chloride Injection Solution
March 25, 2008
Medtronic Neuromodulation SynchroMed EL, SynchroMed II and IsoMed Implantable Infusion Pumps
March 25, 2008
Class I Recall of SynchroMed EL, SynchroMed II, and IsoMed Implantable Infusion Pumps. Reports of inflammatory mass formations at or near the distal tip of intrathecal catheters.
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Tiotropium (marketed as Spiriva HandiHaler)
March 20, 2008
Early Communication about an Ongoing Safety Review. Safety monitoring has identified a possible increased risk of stroke in patients who take Spiriva.
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FDA Drug Safety Newsletter
March 20, 2008
New online issue, including articles on Pharmacogenomics and Drug Safety, safety reviews of Exenatide and acute pancreatitis, PDE5 inhibitors and sudden hearing loss, and TNF-alpha antagonists and serious skin reactions.
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Medtronic AneuRx Stent Graft System
March 20, 2008
Updated information on the mortality risks associated with the use of the AneuRx Stent Graft System to prevent abdominal aortic aneurysm rupture.
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Erythropoiesis Stimulating Agents: Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa)
March 14, 2008
Studies indicate increased mortality and more rapid tumor progression in patients with cancer receiving ESAs.
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Prezista (darunavir)
March 14, 2008
Reports of drug induced hepatitis in patients receiving combination therapy with Prezista/ritonavir.
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Long-Acting Hydrocodone-Containing Cough Product (marketed as Tussionex Pennkinetic Extended-Release Suspension)
March 14, 2008
Blood Glucose Meters and Test Strips
March 14, 2008
Glucose meters used with non-recommended strips may fail to give results or may generate inaccurate results.
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Unapproved Over The Counter Drugs Marketed for Prevention and Treatment of STDs
March 6, 2008
Products sold over the counter make fraudulent claims about preventing and treating sexually transmitted diseases.
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Aspire36, Aspire Lite Dietary Supplements
March 5, 2008
Nationwide recall of dietary supplements because they contain an undeclared drug product that may lower blood pressure to dangerous levels.
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Tamiflu (oseltamivir phosphate)
March 4, 2008
Neuropsychiatric events, including delirium and abnormal behavior leading to injury, associated with the use of Tamiflu.
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Spiriva (tiotropium bromide inhalation powder) and Foradil (formoterol fumarate inhalation powder) Capsules
February 29, 2008
November 2007 Monthly Safety Labeling Changes
February 29, 2008
Summary of revisions to the BOXED WARNINGS, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS labeling sections, and Patient Package Inserts/Medication Guides.
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Tysabri (natalizumab)
February 29, 2008
Reports of clinically significant liver injury, including markedly elevated serum hepatic enzymes and elevated total bilirubin.
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Denture Cleanser Allergic Reactions and Misuse
February 27, 2008
Avandia (rosiglitazone maleate)
February 27, 2008
Fentanyl transdermal system CII Patches
February 20, 2008
Nationwide recall because some patches may have a defect, exposing patients or caregivers directly to fentanyl gel, which may lead to serious adverse events including respiratory depression and overdose.
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Duragesic 25 mcg/hr (fentanyl transdermal system) CII Pain Patches
February 20, 2008
Nationwide recall because some patches may have a cut edge, exposing patients or caregivers directly to fentanyl gel, which may lead to serious adverse events including respiratory depression and possible overdose.
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Heparin Sodium Injection (Baxter)
February 12, 2008
Chattem Icy Hot Heat Therapy Products
February 12, 2008
Nationwide recall because of reports of first, second and third degree burns and skin irritation.
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Botox, Botox Cosmetic (Botulinum toxin Type A), Myobloc (Botulinum toxin Type B)
February 12, 2008
Injectable Colchicine (including drugs containing colchicine)
February 12, 2008
Intravenous colchicine associated with fatal effects including cardiac events and organ failure.
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Medtronic SynchroMed EL Implantable Infusion Pump
February 12, 2008
Class I Recall because of a potential motor stall issue that may suddenly, and without warning, stop drug delivery causing loss of therapy.
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Varenicline (marketed as Chantix)
February 4, 2008
Serious neuropsychiatric symptoms reported, including changes in behavior, agitation, depressed mood, suicidal ideation, and attempted/completed suicide.
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Antiepileptic Drugs
February 1, 2008
FDA's analysis of placebo-controlled clinical studies of eleven antiepileptic drugs showed patients receiving antiepileptic drugs had approximately twice the risk of suicidal behavior or ideation compared to patients receiving placebo.
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NuCel Labs Eye Drops and Eye-Ear Wash Products
February 1, 2008
Ezetimibe/Simvastatin (marketed as Vytorin), Ezetimibe (marketed as Zetia), and Simvastatin (marketed as Zocor)
January 28, 2008
Cordis Corporation Dura Star RX and Fire Star RX PTCA Balloon Catheters
January 28, 2008
Class I recall issued due to a potential for slow deflation or no deflation of the angioplasty balloon when inserted into the artery or other blood vessels.
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Leukine (sargramostim)
January 28, 2008
Liquid formulation of drug withdrawn from the market because of an upward trend in spontaneous reports of adverse reactions.
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Ortho Evra Contraceptive Transdermal Patch
January 23, 2008
New epidemiology study found that users of the birth control patch were at higher risk of developing serious blood clots than women using birth control pills.
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Heparin Sodium Injection 1000 units/mL 1OmL and 30 mL Vials
January 23, 2008
Voluntary recall of certain lots of Heparin as a precaution due to an increase in reports of adverse patient reactions associated with these lots.
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Heparin and Normal Saline Pre-Filled Syringe Flushes
January 23, 2008
Cough and Cold Medications in Children Less Than Two Years of Age
January 23, 2008
Nonprescription cough and cold medicine should not be used for children under 2 years of age.
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Edetate Disodium (marketed as Endrate and generic products)
January 23, 2008
Important safety considerations for healthcare professionals until the FDA's ongoing evaluation of the risks and benefits of Edetate Disodium is complete.
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Unretrieved Device Fragments
January 23, 2008
Compounded Menopause Hormone Therapy Drugs
January 15, 2008
Pharmacy operations warned that the claims the pharmacies are making about the safety and effectiveness of their "bio-identical hormone replacement therapy" or "BHRT" products are unsupported by medical evidence, and are considered false and misleading by the Agency.
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Bisphosphonates (marketed as Actonel, Actonel+Ca, Aredia, Boniva, Didronel, Fosamax, Fosamax+D, Reclast, Skelid, and Zometa)
January 8, 2008
Possibility of severe and sometimes incapacitating bone, joint, and/or muscle pain in patients taking bisphosphonates.
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Super Shangai, Strong Testis, Shangai Ultra, Shangai Ultra X, Lady Shangai, Shangai Regular (also known as Shangai Chaojimengnan)
January 8, 2008
Products marketed as dietary supplements contain undeclared active ingredients of products used to treat erectile dysfunction.
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Bayer Diabetes Care Contour Test Strips (TS)
January 8, 2008
Market Recall because test strips from specific lots could result in blood glucose readings with a positive bias that could demonstrate 5 - 17% higher test results.
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Heparin Lock Flush Solution (Pre-Filled 5 ml in 12 ml Syringes)
January 8, 2008
Fentanyl Transdermal System (marketed as Duragesic and generics)
January 8, 2008
Updated information on appropriate prescribing, dose selection, and safe use of the Fentanyl Transdermal System.
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OTC and Dietary Supplement Reporting
December 21, 2007
New adverse event reporting requirements for manufacturers, packers, or distributors of dietary supplements and non-prescription (OTC) drug products
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Nonoxynol 9 (N9) OTC Contraceptive Products
December 19, 2007
FDA Final Rule that N9 does not protect against infection from HIV (the virus that causes AIDS) and sexually transmitted diseases.
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PedvaxHIB (Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)), COMVAX (Haemophilus b Conjugate (Menigococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine)
December 18, 2007
Voluntary recall because the manufacturer cannot assure the sterility of affected lots of vaccine.
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Electric Dental Handpieces
December 13, 2007
Reports of serious patient injuries, including third degree burns, associated with the use of poorly maintained electric dental handpieces during dental procedures.
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Radio Frequency Ablation Devices
December 13, 2007
Reports of patient deaths associated with the use of radio frequency (RF) ablation devices during lung tumor ablation.
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Carbamazepine (marketed as Carbatrol, Equetro, Tegretol and generics)
December 13, 2007
Dangerous or even fatal skin reactions (Stevens Johnson syndrome and toxic epidermal necrolysis), that can be caused by carbamazepine therapy, are significantly more common in patients with a particular human leukocyte antigen (HLA) allele, HLA-B*1502.
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Vail Products Enclosed Bed Systems
December 10, 2007
Hospitals, nursing homes and consumers advised to stop using the bed system and move patients to an alternate bed.
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Desmopressin Acetate (marketed as DDAVP Nasal Spray, DDAVP Rhinal Tube, DDAVP, DDVP, Minirin, ad Stimate Nasal Spray)
December 5, 2007
Certain patients taking desmopressin are at risk of developing severe hyponatremia that can result in seizures and death.
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Myfortic (mycophenolic acid) Delayed-Release Tablets
November 29, 2007
Use of drug during pregnancy associated with increased risks of pregnancy loss and congenital malformations.
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Encore Supplement Tablets
November 27, 2007
Chantix (Varenicline)
November 21, 2007
Reports of suicidal thoughts and aggressive and erratic behavior in patients who have taken Chantix.
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Age Intervention Eyelash
November 20, 2007
Product seized because it contains an unapproved drug ingredient, makes unapproved drug claims, and could cause eye damage.
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Thoratec Implantable Ventricular Assist Devices
November 19, 2007
Class I Recall due to potential for air leaks to develop in the pneumatic driveline if the device is implanted in the external position.
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Avandia (rosiglitazone maleate) Tablets
November 15, 2007
New information added to existing boxed warning in prescribing information about potential increased risk for heart attacks.
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Cefepime (marketed as Maxipime)
November 15, 2007
Early communication about the ongoing review of new safety data to evaluate the risk of death in patients treated with cefepime.
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Erythropoiesis Stimulating Agents (ESAs): Aranesp (darbepoetin alfa), Epogen (epoetin alfa), and Procrit (epoetin alfa)
November 13, 2007
FDA strengthens boxed warnings and approves other safety labeling changes for erythropoiesis-stimulating agents.
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Trasylol (aprotinin injection)
November 5, 2007
Marketing suspension of Trasylol announced, pending detailed review of preliminary results from a Canadian study that suggested an increased risk for death.
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Welch Allyn AED 10 Automatic External Defibrillators
November 5, 2007
Class I recall issued dues to a possibility that the recalled devices may experience failure or unacceptable delay in analyzing a patient’s ECG, resulting in possible failure to deliver the appropriate therapy.
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Cleaners and Disinfectants: Hazards of Excess Use on Electronic Medical Equipment
November 5, 2007
Public Health Notification issued describing hazards of using excess cleaning and disinfecting liquids on certain electronic medical equipment. The notification includes recommendations to avoid these hazards.
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NC Solution (antifungal product)
November 5, 2007
Healthcare professionals and consumers informed of the seizure of NC Solution and other drugs for human or animal use, dietary supplements, and ingredients to make those products. NC Solution lacked FDA approval.
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CellCept (mycophenolate mofetil)
October 30, 2007
Changes to prescribing information due to increased risk of first trimester pregnancy loss and increased risk of congenital malformations.
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September 2007 Monthly Safety Labeling Changes
October 29, 2007
Summary of revisions to the Boxed Warning, Contraindications, Warnings, Precautions, Adverse Reactions sections, and Patient Package Insert/Medication Guide.
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Aprotinin Injection (marketed as Trasylol)
October 25, 2007
Patient enrollment in the Aprotinin treatment group arm of BART study stopped due to preliminary findings that suggest an increased risk of death associated with aprotinin compared to other antifibrinolytic drugs.
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Provigil (modafinil) Tablets
October 24, 2007
Warnings added to prescribing information regarding serious rash, including Stevens-Johnson Syndrome (SJS) and hypersensitivity reactions, and psychiatric symptoms.
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PDE5 Inhibitors - Viagra (sildenafil), Cialis (tadalafil), Levitra (vardenadil), Revatio (sildenafil)
October 18, 2007
Byetta (exenatide)
October 17, 2007
Medtronic Sprint Fidelis Defibrillator Leads
October 16, 2007
Distribution voluntarily suspended because a small number of fractures have been detected. Fractured leads may send false signals that cause inappropriate defibrillator shocks, or therapies such as pacing or shocks may not be delivered.
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Charantea Ampalaya Capsules and Charantea Ampalaya Tea by FullLife Natural Options, Inc.
October 16, 2007
Micro-bubble Contrast Agents
October 16, 2007
Reports of deaths and serious cardiopulmonary reactions following the administration of ultrasound micro-bubble contrast agents used in echocardiography.
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Cochlear Implants with a Positioner
October 11, 2007
FDA advises recipients of cochlear implants of the importance of being fully immunized against bacterial meningitis caused by Streptococcus pneumoniae.
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August 2007 Monthly Safety Labeling
October 2, 2007
Revisions to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS labeling sections, and Patient Package Insert/Medication Guides.
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October 2007 Patient Safety News
October 2, 2007
October 2007 Patient Safety News, a video news show for healthcare professionals covering safety alerts, recalls, product approvals, and important tips on protecting patients, was posted to the FDA website.
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Hydrocodone in Unapproved Prescription Products
October 1, 2007
Baxa Corporation Exacta-Mix 2400 Operating Software Version 1.07 Pharmacy Compound System
September 28, 2007
Axcil and Desirin (marketed as dietary supplements)
September 26, 2007
TWC Global LLC, Inc., issues a nationwide recall of Axcil and Desirin, both marketed as dietary supplements, because they were found to contain potentially harmful, undeclared ingredients.
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Baby's Bliss Gripe Water, Apple flavor
September 26, 2007
MOM Enterprises recalled Baby's Bliss Gripe Water, apple flavor, with a code of 26952V and expiration date of 10-08 due to cryptosporidium infection.
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MRL Welch Allyn AED 20 Automatic External Defibrillators
September 19, 2007
FDA Drug Safety Newsletter
September 18, 2007
A new FDA publication for healthcare professionals and the medical community covering the findings of selected postmarketing drug safety reviews, as well as information on important emerging drug safety issues and recently approved new molecular entities.
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Haloperidol (marketed as Haldol, Haldol decanoate, and Haldol lactate)
September 17, 2007
Revision to the WARNINGS section of the prescription information to include Torsades the Pointes and QT prolongation especially with an intravenous or higher than recommended dose administration.
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B. Braun Medical Inc. Normal Saline Flush Syringes
September 17, 2007
Nationwide recall of product with lot number ending in "SFR" due to presence of medical grade silicone in the saline.
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Fentora (fentanyl buccal tablet)
September 14, 2007
Serious adverse events, including deaths, have occurred in patients treated with Fentora. These deaths occurred as a result of improper patient selection (e.g., use in opioid non-tolerant patients), improper dosing, and/or improper product substitution.
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Abbott Blood Glucose Meters
September 12, 2007
Abbott notified users of Precision Xtra, Optimum, ReliOn Ultima, Rite Aid, and Kroger blood glucose meters to check the meter's display screen.
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July 2007 Monthly Safety Labeling Changes
September 10, 2007
Viracept (nelfinavir mesylate)
September 10, 2007
Guidance on the use of Viracept in pregnant women and pediatric patients due to the presence of ethyl methanesulfonate (EMS), a process-related impurity which is a potential human carcinogen.
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Zencore Tabs
September 7, 2007
Product marketed as a dietary supplement recalled because it was found to contain potentially harmful ingredients.
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June 2007 Monthly Safety Labeling Cbanges
August 23, 2007
Codeine Products Used By Nursing Mothers
August 20, 2007
Use of products containing codeine by some breastfeeding mothers may lead to life-threatening side effects in nursing babies.
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Warfarin (marketed as Coumadin)
August 17, 2007
New genetic information may help providers improve initial dosing estimates of warfarin (Coumadin) for individual patients.
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Baraclude (entecavir) Tablets and Oral Solution
August 17, 2007
Baraclude therapy is not recommended for HIV/hepatitis B virus (HBV) co-infected patients who are not also receiving highly active antiretroviral therapy (HAART)
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Nonprescription Cough and Cold Medicine Use in Children
August 15, 2007
Baxter Healthcare Corporation COLLEAGUE And FLO-GARD Volumetric Infusion Pumps
August 15, 2007
Repair, Service, or Testing May Not Have Been Performed on Certain Baxter COLLEAGUE and FLO-GARD Infusion Pumps
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Kaletra (lopinavir/ritonavir) Oral Solution
August 15, 2007
Abbott Laboratories disseminated a Dear Healthcare Provider Letter to physicians and pharmacists that prescribe/distribute Kaletra Oral Solution.
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Red Yeast Rice, Red Yeast Rice/Policosonal Complex, Cholestrix
August 10, 2007
Consumers warned to avoid Red Yeast Rice products because they may contain an unauthorized drug that could be harmful to their health.
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Omeprazole (marketed as Prilosec and generic products), Omeprazole plus Sodium Bicarbonate (marketed as Zegerid), Nexium (esomeprazole)
August 10, 2007
May 2007 Monthly Safety Labeling
August 2, 2007
Summary of revisions to the Boxed Warning, Contraindications, Warnings, Precautions, Adverse Reactions sections, and Patient Package Insert/Medication Guide.
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Baxter Healthcare Corporation COLLEAGUE And FLO-GARD Volumetric Infusion Pumps
July 30, 2007
Thoratec Paracorporeal Ventricular Assist System (PVAD)
July 30, 2007
Thoratec TLC-II Portable Ventricular Assist Device (VAD) Driver
July 30, 2007
Class I Recall issued because the VAD driver may stop due to earlier than expected wear-out of the compressor motor.
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Baxter Healthcare Upgraded COLLEAGUE Triple Channel Volumetric Infusion Pumps
July 24, 2007
April 2007 Monthly Safety Labeling
July 18, 2007
Summary of revisions to the Boxed Warning, Contraindications, Warnings, Precautions, Adverse Reactions sections, and Patient Package Insert/Medication Guide.
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Bayer Ascensia Contour Blood Glucose Monitoring System
July 16, 2007
Class 1 Recall issued because the meters reported the wrong unit of measure for Canadian users.
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Rocephin (ceftriaxone sodium) for Injection
July 9, 2007
Prescribing Information revised to provide new information regarding the potential risk associated with concomitant use of Rocephin with calcium or calcium containing solutions or products.
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Invanz (ertapenem sodium) Injection
July 9, 2007
Three lots recalled because the product may contain broken glass pieces in the reconstituted solution for injection.
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Xolair (omalizumab)
July 5, 2007
Prescribing information revised to include a BOXED WARNING and MEDICATION GUIDE about the risk of anaphylaxis when taking Xolair.
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Colistimethate (marketed as Coly-Mycin M and generic products)
July 5, 2007
FDA is investigating the connection between the use of pre-mixed liquid form of Colistimethate and death of a cystic fibrosis patient.
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Diprivan (propofol)
June 15, 2007
Reports of patients who experienced chills, fever, and body aches shortly after receiving propofol for sedation or general anesthesia.
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RotaTeq (Rotavirus, Live, Oral, Pentavalent) Vaccine
June 15, 2007
Changes made to the product's prescribing information to include information about six cases of Kawasaki disease observed during the Phase 3 clinical trial.
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Long Weekend Dietary Supplement
June 15, 2007
Abbott Laboratories Architect Stat Troponin-1 Immunoassay
June 11, 2007
Class 1 Recall due to inconsistent or invalid test results at very low levels of troponin-1.
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Alcon Refractive Horizons LADAR6000 Excimer Laser System
June 5, 2007
Class I Recall because use of the CustomCornea algorithm for myopia with and without astigmatism with the LADAR6000 Excimer Laser caused corneal abnormalities.
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Toothpaste Imported From China May Contain Diethylene Glycol
June 4, 2007
FDA warns consumers to avoid using any toothpaste labeled "Made in China" because the toothpaste may contain diethylene glycol, a substance used in antifreeze and as a solvent.
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Abbott Similac Special Care 24 Cal/fl. oz. Ready-to-Feed Premature Infant Formula with Iron
May 30, 2007
Advanced Medical Optics Complete MoisturePlus Contact Lens Solution
May 30, 2007
Recall due to reports of a serious, but rare eye infection (Acanthamoeba keratitis) that may cause permanent loss or significant loss of vision resulting in the need for a corneal transplant.
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Unapproved Guaifenesin Timed-Release Drug Products
May 28, 2007
FDA intends to take action against companies that market unapproved drug products in timed-release dosage form that contain guaifenesin.
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Integra LifeSciences EnDura No-React Dural Substitute
May 28, 2007
Gadolinium-Based Contrast Agents for Magnetic Resonance Imaging (MRI): Magnevist, MultiHance, Omniscan, OptiMARK, ProHance
May 23, 2007
FDA requests that Boxed Warning and new warnings be added to products' prescribing information about the risk of nephrogenic systemic fibrosis.
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Exjade (deferasorix) Tablets For Oral Suspension
May 23, 2007
Changes made to the WARNINGS and ADVERSE REACTION sections of prescribing information regarding post marketing reports of acute renal failure and hematological disorders.
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Avandia (rosiglitazone)
May 23, 2007
Ongoing analysis of safety data showed differing rates of ischemic cardiovascular events including heart attack or heart-related adverse events, some fatal, relative to other drugs used to treat diabetes mellitus.
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Caffeine Citrated, Powder, Purified
May 23, 2007
Product recalled because of potential sub potency that may lead to sub-therapeutic caffeine blood levels and an unacceptable risk of respiratory depression in premature infants.
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NBTY Shark Cartilage Capsules
May 18, 2007
OxyContin
May 10, 2007
True Man and Energy Max Products
May 10, 2007
Health risk alert issued because products contain undeclared ingredients that may interact with nitrates and may lower blood pressure to dangerous levels.
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Glycerin compounded products
May 8, 2007
FDA warns manufacturers and preparers of pharmaceutical products containing glycerin of the importance of assuring that the glycerin used is not contaminated with diethylene glycol.
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Ortho-Clinical Diagnostics Vitros Immunodiagnostic Products Troponin I Reagent Pack
May 8, 2007
Nationwide recall because shifts in test results could contribute to a missed diagnosis of myocardial infarction.
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Antidepressant Medication Products
May 3, 2007
FDA proposes that manufacturers of antidepressants update product labeling to include new warnings about suicidal thinking and behavior in young adults.
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Colchicine Compounded Injectable Products
May 3, 2007
Warning About Counterfeit Drugs From Multiple Internet Sellers
May 2, 2007
Multiple websites, which appear to be operated from outside the United States, may be involved in the distribution of counterfeit prescription drugs.
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PharmaFab Inc., manufacturer and distributor of prescription and over-the-counter drug products
April 26, 2007
PharmaFab Inc., manufacturer of unapproved and adulterated drugs agrees to stop illegal practices.
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ResMed S8 Flow Generators (Continuous Positive Air Pressure or CPAP)
April 25, 2007
Avastin (bevacizumab)
April 23, 2007
Formation of tracheoesophageal fistula exceeds the background rate in a study of patients receiving chemotherapy and radiation plus Avastin for the treatment of limited-stage small cell lung cancer.
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Shelhigh, Inc. Implantable Medical Devices
April 23, 2007
FDA seized all implantable medical devices manufactured by Shelhigh, Inc., after finding significant deficiencies in the company’s manufacturing processes.
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Boston Scientific/Guidant CONTAK RENEWAL 3 and 4, VITALITY, and VITALITY 2 implantable cardiac defibrillators and cardiac resynchronization therapy defibrillators
April 16, 2007
Certain units recalled because a faulty capacitor in the devices can cause the batteries to deplete sooner than expected.
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Zanaflex (tizanidine hydrochloride) Tablets and Capsules
April 16, 2007
Changes to the CONTRAINDICATIONS and WARNINGS Sections of the approved product labeling about the coadministration of tizanidine with fluvoxamine and ciprofloxacin.
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Ziagen (abacavir sulfate) Tablets, Combivir (lamivudine and zidovudine) Tablets
April 16, 2007
Grifulvin V (griseofulvin), Griseofulvin Oral Suspension
April 16, 2007
Nationwide recall due to reports of glass fragments found in bottles of the liquid formulation.
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Trimethobenzamide Hydrochloride Suppositories
April 16, 2007
March 2007 Monthly Safety Labeling Changes
April 16, 2007
Summary of revisions to the Boxed Warning, Contraindications, Warnings, Precautions, Adverse Reactions sections, and Patient Package Insert/Medication Guide.
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April 2007 Patient Safety News
April 16, 2007
The April 2007 of FDA Patient Safety News was posted. This video news program for healthcare professionals covers safety alerts, recalls, product approvals, and important tips on protecting patients.
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Zelnorm (tegaserod maleate)
April 16, 2007
Product withdrawn from the market. Study results showed patients on Zelnorm had higher risk of serious cardiovascular adverse events.
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Permax (pergolide)
April 16, 2007
Product withdrawn from the market. New studies showed that some patients with Parkinson's disease treated with pergolide had serious damage to their heart valves.
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Accutane (isotretinoin)
April 16, 2007
Special webpage launched to warn consumers and healthcare professionals about the dangers of buying isotretinoin online.
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DermaFreeze365 Products
April 16, 2007
Smith and Nephew RF Denervation Probes
April 16, 2007
Class I recall due to product being mislabeled as sterile which could result in a patient infection.
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Ketek (telithromycin)
April 16, 2007
HoMedics Heating Pads
April 16, 2007
V.Max supplement product
April 16, 2007
Nationwide recall of a supplement product found to contain an undeclared drug, aminotadalafil, which may interact with nitrates found in some prescription drugs and lower blood pressure to dangerous levels.
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Safety & Supplies Co. Inc. - One Touch - Class 1 Recall
March 3, 2007
Becton Dickinson & Company - BD Integra - Class 2 Recall
March 3, 2007
BD Integra 1ml Insulin Syringe with Retracting Precision Guide Needle 1 ml 29g 1/2'' (0.33mm x 13 mm) Re-Order No. 305282 U-100 insulin Lot 6073436
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Abbott Laboratories - Abbott Diagnostics CELL-DYN Diluent/Sheath Reagent - Class 3 Recall
March 1, 2007
CELL-DYN Diluent/Sheath Reagent, for use with CELL-DYN Ruby, Sapphire and 4000 systems. List #01H73-01. Packaged in 20 Liter cubitainers.
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Siemens Medical Solutions Diagnostics - SMS - Class 2 Recall
March 1, 2007
Alcon Laboratories, Inc - Custom-Pak¿ Surgical Packs - Class 2 Recall
March 1, 2007
Alcon Custom-Pak¿, part #10975-02, containing BD Beaver¿ Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.
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Alcon Laboratories, Inc - Custom-Pak¿ Surgical Packs - Class 2 Recall
March 1, 2007
Alcon Custom-Pak¿, part #4917-54, containing BD Beaver¿ Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.
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Alcon Laboratories, Inc - Custom-Pak¿ Surgical Packs - Class 2 Recall
March 1, 2007
Alcon Custom-Pak¿, part #11148-02, containing BD Beaver¿ Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.
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Alcon Laboratories, Inc - Custom-Pak¿ Surgical Packs - Class 2 Recall
March 1, 2007
Alcon Custom-Pak¿, part #6515-51, containing BD Beaver¿ Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.
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Alcon Laboratories, Inc - Custom-Pak¿ Surgical Packs - Class 2 Recall
March 1, 2007
Alcon Custom-Pak¿, part #2638-17, containing BD Beaver¿ Mini-Blade (part #BD6400 or part #BD6900); individual blades repackaged into custom ophthalmic surgical packs and resterilized by Alcon Laboratories, Inc., Houston, TX.
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St. Jude Medical / Daig Division - FastCath - Class 2 Recall
March 1, 2007
FastCath Transseptal Catheter Introducers with Hemostasis Valve, DAIG division of St. Jude Medical, Minnetonka, MN, consists of a radiopaque sheath and dilator; Product # 406850.
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Advanced Medical Optics, Inc. - COMPLETE MoisturePLUS & COMPLETE Amino Moist - Class 2 Recall
March 1, 2007
COMPLETE MoisturePLUS Multi-Purpose Solution (US and Asia Pacific markets, excluding Japan) & COMPLETE Amino Moist Multi-Purpose Solution (Japan only)
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Advanced Medical Optics, Inc. - Krystal Klear Rinse - Class 2 Recall
March 1, 2007
Advanced Medical Optics, Inc. - COMPLETE Multi-Purpose, 10 Minute, Comfort 8 in 1, Comfort Plus, and Protec - Class 2 Recall
March 1, 2007
COMPLETE Multi-Purpose Solution (Asia Pacific markets, excluding Japan, Korea and Thailand), COMPLETE 10 Minute (Japan only), Comfort 8 in 1 Solution (Indonesia only), COMPLETE Comfort Plus All in One Solution (Korea only) & COMPLETE Protec Formula Multi-Purpose Solution (Thailand only)
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Advanced Medical Optics, Inc. - Complete Blink N Clean - Class 2 Recall
March 1, 2007
Advanced Medical Optics, Inc. - Lens Plus Ocupure - Class 2 Recall
March 1, 2007
Lens Plus Ocupure Saline Sterile Rinsing Solution (Asia Pacific markets, excluding Japan) & Consept Rinsing Solution (Japan only)
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Clark Research and Development Inc - Clark Biocompatible Hemoperfusion - Class 2 Recall
February 28, 2007
Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized polymer over acitivated carbon, 50mL, Clark Research and Development, Inc. Folsom, LA 70437
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Clark Research and Development Inc - Clark Biocompatible Hemoperfusion - Class 2 Recall
February 28, 2007
Clark Biocompatible Hemoperfusion Cartridge, sorbent: Heparinized polymer over acitivated carbon, 250mL, Clark Research and Development, Inc. Folsom, LA 70437
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Clark Research and Development Inc - Clark Biocompatible Hemoperfusion - Class 2 Recall
February 28, 2007
Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized polymer over acitivated carbon, 100mL, Clark Research and Development, Inc. Folsom, LA 70437
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Clark Research and Development Inc - Clark Biocompatible Hemoperfusion - Class 2 Recall
February 28, 2007
Clark Biocompatible Hemoperfusion Cartridge, Sorbent: Heparinized polymer over acitivated carbon, 175 mL, Clark Research and Development, Inc. Folsom, LA 70437
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Biosense Webster, Inc. - PREFACE - Class 2 Recall
February 28, 2007
Biosense Webster PREFACE Guiding Sheath, Multipurpose Short, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803MS
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Biosense Webster, Inc. - PREFACE - Class 2 Recall
February 28, 2007
Biosense Webster PREFACE Guiding Sheath, Multipurpose 62cm, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803M
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Biosense Webster, Inc. - PREFACE - Class 2 Recall
February 28, 2007
Biosense Webster PREFACE Guiding Sheath, Multipurpose 77cm, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301805M
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Biosense Webster, Inc. - PREFACE - Class 2 Recall
February 28, 2007
Biosense Webster PREFACE Guiding Sheath, Anterior, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803A
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Biosense Webster, Inc. - PREFACE - Class 2 Recall
February 28, 2007
Biosense Webster PREFACE Guiding Sheath, Posterior, for the introduction of intravascular electrophysiology catheters into any cardiac chamber. Catalog Number 301803P
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GMP Companies/Lifesync Corporation - Life Sync Leadwear Disposable - Class 2 Recall
February 27, 2007
Hospira Inc. - LifeShield Omni-Flow Primary I.V. Pump Set - Class 2 Recall
February 27, 2007
LifeShield Latex-Free Primary I.V. Pump Set with Distal Microbore Patient Line and Gravity Flow Prevention Valve, Convertible Pin, 110 Inch with High-Pressure Filter, Orange Polyethylene-Lined/Light Resistant Tubing and Option-Lok for use with Omni-Flow Medication Management System; Hospira, Inc., Lake Forest, IL 60045 USA, Made in Costa Rica; list 12163-01
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Terumo Cardiovascular Systems Corp - Terumo perfusion cannulae - Class 3 Recall
February 27, 2007
Terumo L Series 1863 type arterial perfusion cannulae, straight open tip, 1/4'' connector, arterial cannula, 10 FR, 17.5 cm (7'') long; Catalog no. L7350.
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Terumo Cardiovascular Systems Corp - Terumo perfusion cannulae - Class 3 Recall
February 27, 2007
Terumo L Series 1863 type arterial perfusion cannulae, straight open tip, 1/4'' connector, arterial cannula, 12 FR, 17.5 cm (7'') long; Catalog no. L7351.
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Stryker Leibinger USA - Stryker TOM - Class 2 Recall
February 27, 2007
Stryker Tom Tessier Osseous Microtome: Plug for Bone Mill Systems (Parts 01-15400 and 01-15401), Stryker Leiblinger Inc., Kalamazoo, MI; Part 01-15407.
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Spacelabs Healthcare, Incorporated - Ultraview SL Command Module/Multiparameter input module - Class 2 Recall
February 27, 2007
Exactech, Inc. - Optetrak - Class 2 Recall
February 27, 2007
Polyethylene tibial posterior stabilized components. Optetrak All Poly Tibial PS Component. Knee prosthesis. Catalog number : 204-11-13
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Diagnostic Chemicals, Ltd. - Diagnostic Chemicals Limited - Class 3 Recall
February 27, 2007
Steris Corporation - Cmax Surgical Table - Class 2 Recall
February 23, 2007
Cmax Surgical Table, Model No. 2182625, Manufactured by STERIS Corporation, 2720 Gunter Park East, Montgomery, AL 36109 USA, TEL: 334 277 6660, FAX: 334 271 5450
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Siemens Medical Solutions USA, Inc. - Symbia S Series SPECT System with a Pinhole Collimator - Class 2 Recall
February 23, 2007
Symbia S Series SPECT (Single-Photon Emission Computed Tomography) System with a Pinhole Collimator; Siemens Medical Solutions USA, Inc., Molecular Imaging, 2501 N. Barrington Road, Hoffman Estates, IL 60195-5203 USA; part number 08717741
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Siemens Medical Solutions USA, Inc. - Symbia T Series SPECT-CT System with a Pinhole Collimator - Class 2 Recall
February 23, 2007
Symbia T Series SPECT-CT (Single-Photon Emission Computed Tomography and Computed Tomography) System with a Pinhole Collimator; Siemens Medical Solutions USA, Inc., Molecular Imaging, 2501 N. Barrington Road, Hoffman Estates, IL 60195-5203 USA; part number 08717733
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Cook Endoscopy - Quantum TTC Biliary Balloon Dilation Catheter - Class 2 Recall
February 22, 2007
Quantum TTC Biliary Balloon Dilation Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
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Skytron, Div. The KMW Group, Inc - Skytron Infinity series (also called Astro series) minor surgery light - Class 2 Recall
February 22, 2007
Skytron Infinity series (also called Astro series) minor surgery light, 3 bulbs in 1 - 19' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Japan; Models IN19, IN19EL, IN19LH and IN19S.
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Skytron, Div. The KMW Group, Inc - Skytron Infinity Series surgical light - Class 2 Recall
February 22, 2007
Skytron Infinity Series surgical light with dual lightheads, 4 bulbs in each of 2 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF5454 and IF5454EL.
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Skytron, Div. The KMW Group, Inc - Skytron Infinity Series surgical light - Class 2 Recall
February 22, 2007
Skytron Infinity Series surgical light with triple lightheads, 4 bulbs in each of 3 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF545454 and IF545454EL.
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Skytron, Div. The KMW Group, Inc - Skytron Infinity Series surgical light - Class 2 Recall
February 22, 2007
Skytron Infinity Series surgical light, 4 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF54, IF54EL, IF54LH and IF54S.
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Skytron, Div. The KMW Group, Inc - Skytron Infinity series (also called Astro series) minor surgery light - Class 2 Recall
February 22, 2007
Skytron Infinity Series (also called Astro series) minor surgery light with dual lightheads, 3 bulbs in each of 2 - 19' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IN1919 and IN1919EL and IN1919EL/PT.
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Skytron, Div. The KMW Group, Inc - Skytron Infinity Series surgical light - Class 2 Recall
February 22, 2007
Skytron Infinity Series surgical light, 5 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF22, IF22B, IF22LH, IF22LHH-B, IF22M-S, IN22, IN22EL, IN22LH and IF22(EL).
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Skytron, Div. The KMW Group, Inc - Skytron Infinity Series surgical light - Class 2 Recall
February 22, 2007
Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in 1 - 22' lighthead and 8 bulbs in 1 - 30' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Model IF3022B. (note only the 22'' lighthead is affected.)
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Skytron, Div. The KMW Group, Inc - Skytron Infinity Series surgical light - Class 2 Recall
February 22, 2007
Skytron Infinity Series surgical light with triple lightheads, 8 bulbs in 1 - 30' diameter lighthead and 5 bulbs in each of 2 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Model IN302222EL, IF302222-B, IN30AR2222EL and IN30TV2222EL. (note only the 22'' lightheads are affected).
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Skytron, Div. The KMW Group, Inc - Skytron Infinity Series surgical light - Class 2 Recall
February 22, 2007
Skytron Infinity Series surgical light with dual lightheads, 8 bulbs in 1 - 30' diameter lighthead and 5 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IN3022EL and IF3022EL. (note only the 22'' lighthead is affected).
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Skytron, Div. The KMW Group, Inc - Skytron Infinity Series surgical light - Class 2 Recall
February 22, 2007
Skytron Infinity Series surgical light with triple lightheads, 5 bulbs in each of 3 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF222222-B, IF222222EL and IN222222EL.
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Skytron, Div. The KMW Group, Inc - Skytron Infinity Series surgical light - Class 2 Recall
February 22, 2007
Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in each of 2 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF2222, IF2222-B, IF2222B/PT, IF2222EL and IN2222EL.
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Teknimed SA - OsSatura TCP - Class 3 Recall
February 22, 2007
OsSatura TCP (pure tricalcium phosphate) 3mm granules packaged in glass jars, Part Numbers: 05-6010-050 5cc, 05-6010-100 10cc, 05-6010-150 15cc & 05-6010-300 30cc
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EMD Chemicals Inc - Anaerotest - Class 3 Recall
February 17, 2007
Anaerotest for microbiology Specification: Performance Test Anerobic: white within 4-6 hours; aerobic: blue with 20 minutes Merck KgaA 64271 Darmstadt, Germany 1.19034.0002 17.08.06 1 unit UPC 4 022536 667928
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EMD Chemicals Inc - Anaerotest - Class 3 Recall
February 17, 2007
Anaerotest;Microbiology , 50 test strips 1.15112 Store dry and tightly closed. Store at + 15 C to +25C Merck IVD 64271 Darmstadt, Germany
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Philips Ultrasound, Inc. - iE33 Ultrasound System - Class 2 Recall
February 17, 2007
iE33 Ultrasound System (System, imaging, pulsed doppler, ultrasonic and system, imaging, pulsed echo, ultrasonic)
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USA Instruments Incorporated - LATERAL BIOPSY PLATE, For use with the Liberty 9000 8 channel breast coil - Class 2 Recall
February 15, 2007
LATERAL BIOPSY PLATE - For use with the Liberty 9000, 8-Channel Breast Coil. The Lateral Biopsy plate is sent to customers in the following configurations: 1) The plate is purchased in sets of 5 as part number E8800BG 8 Channel Breast Biopsy Lateral Grids (pack of 5 grids) or 2) the plate is purchased in pairs with the following part numbers: M3087JG, which contains Liberty 9000 8-Channel Breast Coil, 2 plates and a manual; G3087JH, which contains 2 plates and a manual; M3335LA, which contains a 3T HD 8 channel Vibrant Breast Array, 2 plates and a manual.
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USA Instruments Incorporated - Disposable biopsy plate - Class 2 Recall
February 15, 2007
The recalled product is the Disposable biopsy plate, part #U1-150131. The biopsy plate is labeled in part: Disposable Biopsy Plate, part U1-150131, For Use with the Liberty 9000 8-Channel Breast Coil, USA Instruments, Inc., Aurora, OH, sterile. The breast biopsy plate is used with GE coils and with OEM coils (coils manufactured for Philips and Hitachi by USA Instruments) during Magnetic Resonance breast biopsy procedures. The disposable biopsy plate for use with GE coils is packaged and sold as a part of catalogue U1-160051, U1-150190, U1-150131. The disposable biopsy plate for use with OEM coils is packaged and sold as part of catalogue U1-150226, U1-150190, U1-155068, U1-160016, U1-160052, U1-160085, U1-160166, U1-160175, 2412158, 2416938, 2417842, and U1-150131.
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USA Instruments Incorporated - Large grid biopsy plate - Class 2 Recall
February 15, 2007
The recalled product is the Large grid biopsy plate, part #2414797. The biopsy plate is labeled in part: Large Grid Biopsy Plate, part 2414797, For Use with the Liberty 9000 8-Channel Breast Coil, USA Instruments, Inc., Aurora, OH, sterile. The breast biopsy plate is used with OEM coils (coils manufactured for Philips and Hitachi by USA Instruments) during Magnetic Resonance breast biopsy procedures. The large grid biopsy plate is packaged and sold as a part of catalogue 2414798 and 2415277.
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USA Instruments Incorporated - Lateral biopsy plate - Class 2 Recall
February 15, 2007
The recalled product is the Lateral biopsy plate, part #2414346. The biopsy plate is labeled in part: Lateral Biopsy Plate, part 2414346, For Use with the Liberty 9000 8-Channel Breast Coil, USA Instruments, Inc., Aurora, OH, sterile. The breast biopsy plate is used with GE coils during Magnetic Resonance breast biopsy procedures. The lateral biopsy plate is packaged and sold as a part of catalogue E8800BG, M3087JG, G3087JH, M3335LA.
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USA Instruments Incorporated - Medial biopsy plate - Class 2 Recall
February 15, 2007
The recalled product is the medial biopsy plate, part #2414342. The biopsy plate is labeled in part: Medial Biopsy Plate, part 2414342, For Use with the Liberty 9000 8-Channel Breast Coil, USA Instruments, Inc., Aurora, OH, sterile. The breast biopsy plate is used with GE coils during Magnetic Resonance breast biopsy procedures. The medial biopsy plate, part #2414342 is packaged and sold as a part of catalogue numbers E8800BF, M3087JG, G3087JH, and M3335LA.
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Alcon Laboratories, Inc - AcrySof¿ ReSTOR¿ Intraocular Lens - Class 2 Recall
February 15, 2007
Alsius Corporation - Alsius Cool Line - Class 2 Recall
February 15, 2007
Alsius Corporation - Alsius Cool Line - Class 2 Recall
February 15, 2007
Alcon Laboratories, Inc - AcrySof¿ Intraocular Lens - Class 2 Recall
February 15, 2007
Alcon Laboratories, Inc - AcrySof¿ ReSTOR¿ Intraocular Lens - Class 2 Recall
February 15, 2007
GE OEC Medical Systems, Inc - Image-intensified fluoroscopic x-ray system. - Class 2 Recall
February 15, 2007
OEC Uroview 2800 with Dual Monitor Option, fluoroscopic x-ray system, Model Numbers: 882082-01, 882082-02, 886765-01, GE Healthcare, Surgery, Salt Lake City, UT.
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GE OEC Medical Systems, Inc - Image-intensified fluoroscopic x-ray system. - Class 2 Recall
February 15, 2007
OEC Uroview 2800 fluoroscopic x-ray system with 3 Phase Power Distribution Box option (Wonder Box) , Model Numbers: 882082-01, 882082-02, 886765-01, GE Healthcare, Surgery, Salt Lake City, UT.
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Ciba Vision Corporation - O¿Optix¿ (lotrafilcon B) Soft Contact Lenses - Class 2 Recall
February 15, 2007
O¿Optix¿ (lotrafilcon B) Soft Contact Lenses, Rx only, Ciba Vision. The product is distributed in 3 packs (3 lenses per package) and 6 packs (6 lenses per package).
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Taut, Inc. - Taut Intraducer Peritoneal Catheter - Class 2 Recall
February 15, 2007
Taut Intraducer Peritoneal Catheter, 12 Fr x 10 Fr x 20.3 cm; a sterile, Rx peritoneal catheter for single use, individually packaged in a Tyvek/clear pouch; Taut Inc., 2561 Kaneville Ct., Geneva, IL 60134; the individually packaged, sterilirzed catheter was sold in two configurations: a) catalog number (REF) P.I.-128: 10 catheters per box, 10 boxes per case, and b) a sterile component of the convenience kit, catalog number (REF) 50000, System One Comprehensive Lap CBDE Kit
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Arjo, Inc. - Sara Active Sling - Narrow - Class 2 Recall
February 15, 2007
Sara Active Sling - Narrow; item KKX053850.0 - models KA1230 (with safety) and KA1240; manufactured by Medibo Medical Products NV, Hanmont, Achel, Belgium, distributed by Arjo Inc., Roselle, IL 60172
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Candela Laser Corporation - Candela Corporation Vbeam Aesthetica Laser System - Class 2 Recall
February 15, 2007
Candela Corporation Vbeam Aesthetica Laser System, Model/Catalog # 9914-00-0320 Vbeam Aesthetica w/ gray enclosure and rose colored display
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Candela Laser Corporation - Candela Corporation Vbeam Aesthetica Laser System - Class 2 Recall
February 15, 2007
Candela Corporation Vbeam Perfecta Laser System, Model/Catalog # 9914-08-0300 Vbeam Perfecta w/ gray enclosure and gray colored display
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Candela Laser Corporation - Candela Corporation Vbeam Aesthetica Laser System - Class 2 Recall
February 15, 2007
Candela Corporation Vbeam Perfecta Laser System, Model/Catalog # 9914-00-0300 Vbeam Perfecta w/ rose/gray enclosure and rose colored display
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Candela Laser Corporation - Candela Corporation Vbeam Aesthetica Laser System - Class 2 Recall
February 15, 2007
Candela Corporation Vbeam Platinum Laser System, Model/Catalog # 9914-08-0310 Vbeam Platinum w/ gray enclosure and gray colored display
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Candela Laser Corporation - Candela Corporation Vbeam Aesthetica Laser System - Class 2 Recall
February 15, 2007
Candela Corporation Vbeam Platinum Laser System, Model/Catalog # 9914-00-0310 Vbeam Platinum w/ rose gray enclosure and rose colored display
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Candela Laser Corporation - Candela Corporation Vbeam Aesthetica Laser System - Class 2 Recall
February 15, 2007
Candela Corporation Vbeam Aesthetica Laser System, Model/Catalog # 9914-08-0320 Vbeam Aesthetica w/ gray enclosure and gray display
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General Electric Med Systems LLC - GE LightSpeed VCT System - Class 2 Recall
February 15, 2007
The LightSpeed VCT System is intended for head and whole body X-ray Computed Tomography applications.
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Arjo, Inc. - Sara Active Sling - Wide - Class 2 Recall
February 15, 2007
Sara Active Sling - Wide; item KKX00120.0 - models KA1231 (with safety) and KA1241; manufactured by Medibo Medical Products NV, Hanmont, Achel, Belgium, distributed by Arjo Inc., Roselle, IL 60172
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General Electric Med Systems LLC - GE LightSpeed RT16 CT Scanner System - Class 2 Recall
February 15, 2007
The LightSpeed RT16 CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications. The system is capable of generating images for the guidance of minimally invasive procedures such as biopsy and ablation of tumors and pathology. The system allows imaging of obese patients, up to and including the obese population (BMI > 40). When used in the LightSpeed RT 16 configuration, the system acquires CT anatomical images that are clinically useful in the simulation and planning of radiation therapy for the treatment of cancer.
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Arjo, Inc. - Sara Active Sling - Standard - Class 2 Recall
February 15, 2007
Sara Active Sling - Standard; item KK53210.0 - model KA1210 (with safety); manufactured by Medibo Medical Products NV, Hanmont, Achel, Belgium, distributed by Arjo Inc., Roselle, IL 60172
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Abbott Laboratories MPG - IMx Sirolimus Reagent Pack - Class 2 Recall
February 15, 2007
IMx Sirolimus Reagent Pack; list 5C91-21; 100 test pack containing 1 bottle (9.7 mL) Anti-Sirolimus Antibody Coated Microparticles, 1 bottle (9.7 mL) Sirolimus Alkaline Phosphatase Conjugate, and 1 bottle (10 mL) 4-Methylumbelliferyl Phosphate, 1.2 mM; Produced by Axis-Shield Diagnostics, Ltd., Dundee, UK for Abbott Diagnostics Division, Distributed by Abbott Laboratories, Abbott Park, IL 60064 USA
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Stille-Sonesta, Inc - Stille Sonesta Video Fluoroscopy Table 6210 - Class 2 Recall
February 15, 2007
Atrium Medical Corporation - Class 2 Recall
February 15, 2007
Nicolet Biomedical Div of Viasys Healthcare - NicoletOne monitoring system version 5.20 software - Class 3 Recall
February 15, 2007
NicoletOne version 5.20 software (also known as NicoletOne Version 5.2 Software) used with the NicoletOne LTM, Sleep, nEEG, vEEG and ICU monitoring Systems.
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Matrix Distributors, Inc. - Life Scan One Touch Ultra - Class 1 Recall
February 14, 2007
Terumo Cardiovascular Systems Corp - Terumo APS 1 - Class 2 Recall
February 14, 2007
Terumo Cardiovascular Systems Corp - Terumo APS 1 - Class 2 Recall
February 14, 2007
Terumo Cardiovascular Systems Corp - Terumo Advanced Perfusion System - Class 2 Recall
February 14, 2007
Terumo Cardiovascular Systems Corp - Terumo Advanced Perfusion System - Class 2 Recall
February 14, 2007
Terumo Cardiovascular Systems Corp - Terumo APS 1 - Class 2 Recall
February 14, 2007
Terumo Cardiovascular Systems Corp - Terumo APS 1 - Class 2 Recall
February 14, 2007
Terumo Advanced Perfusion System 1; CAPIOX Control Module; Catalog number 811113 (Not distributed within the United States).
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Terumo Cardiovascular Systems Corp - Terumo APS 1 - Class 2 Recall
February 14, 2007
Terumo Advanced Perfusion System 1; Integrated (Sarns) Centrifugal System Control Unit; Catalog number 801046.
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Terumo Cardiovascular Systems Corp - Terumo APS 1 - Class 2 Recall
February 14, 2007
Terumo Cardiovascular Systems Corp - Terumo APS 1 - Class 2 Recall
February 14, 2007
Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763.
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Terumo Cardiovascular Systems Corp - Terumo APS 1 - Class 2 Recall
February 14, 2007
Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).
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Terumo Cardiovascular Systems Corp - Terumo APS 1 - Class 2 Recall
February 14, 2007
Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763.
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Terumo Cardiovascular Systems Corp - Terumo APS 1 - Class 2 Recall
February 14, 2007
Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States).
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Terumo Cardiovascular Systems Corp - Terumo APS 1 - Class 2 Recall
February 14, 2007
MAQUET Inc. - Maquet Critical Care Ventilator System - Class 2 Recall
February 10, 2007
Thoratec Corp - Thoratec Dual Drive Console - Class 2 Recall
February 10, 2007
Thoratec Dual Drive Console a drive component of the Thoratec Ventricular Assist Device, Model Numbers, 10025-2600-005, 10025-2601-007, 10025-2602-006, Thoratec Corporation, 6035 Stoneridge Drive, Pleasanton, CA 94588
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