Archived Content

The content on this page is provided for reference purposes only. This content has not been altered or updated since it was archived.

Safety

2010 Safety Alerts for Human Medical Products

Stay Informed

red envelope Sign up for MedWatch email updates  
[About the MedWatch E-list]

RSS MedWatch Safety Alerts RSS Feed  [What is RSS?]

Follow Us On Twitter Follow MedWatch on Twitter

Items in the following lists are in alphabetical order. Click "Date Issued" to re-order the items in a list by date. Click "Product Name" to re-order the items alphabetically.

MedWatch "What's New" Archive, Jan 1 - Dec 31, 2010

Drugs and Therapeutic Biological Products

Product NameDate Issued/Updated
Actos (pioglitazone): Ongoing Safety Review - Potential Increased Risk of Bladder Cancer 06/15/2011
Advair Diskus (fluticasone propionate and salmeterol inhalation powder): Stolen Product Warning [ARCHIVED] 07/16/2010
Alli 60 mg capsules (120 count refill kit): Counterfeit Product [ARCHIVED] 01/23/2010
Angiotensin Receptor Blockers (ARBs): Drug Safety Communication - Drug Safety Review Completed [ARCHIVED] 06/02/2011
Anzemet (dolasetron mesylate): Drug Safety Communication - Reports of Abnormal Heart Rhythms [ARCHIVED] 12/17/2010
Arava (leflunomide): Boxed Warning - Risk of Severe Liver Injury [ARCHIVED] 07/13/2010
Aromatase Inhibitors in Products Marketed as Dietary Supplements: Recall [ARCHIVED] 10/08/2010
Arrow Brand Medicated Oil and Embrocation: Consumer Warning, Product Considered Toxic [ARCHIVED] 05/28/2010
Avandia (rosiglitazone): REMS - Risk of Cardiovascular Events [ARCHIVED] 11/04/2011
Avandia (rosiglitazone): Ongoing Review of Cardiovascular Safety [ARCHIVED] 02/22/2010
Avastin (bevacizumab): Process for Removal of Breast Cancer Indication Begun [ARCHIVED] 12/16/2010
Benadryl Extra Strength Itch Stopping Gel: Packaging Changes to Reduce Use Errors [ARCHIVED] 05/12/2010
Benicar (olmesartan): Ongoing Safety Review 04/14/2011
Bisphosphonates (Osteoporosis Drugs): Label Change - Atypical Fractures Update [ARCHIVED] 10/13/2010
Camolyn eye drops, Fisiolin nasal drops: Voluntary recall due to non-sterility [ARCHIVED] 04/07/2010
Chelation Products: Unapproved Over-the-Counter Drugs - Consumer Warning [ARCHIVED] 10/14/2010
Coumadin 1 mg Tablet Blister Packs: Recall [ARCHIVED] 07/14/2010
Cubicin (daptomycin): Drug Safety Communication - Risk of Eosinophilic Pneumonia [ARCHIVED] 07/29/2010
Dexamethasone Sodium Phosphate Injection, 4 mg/mL, 30 mL Multiple Dose Vial: Recall due to Particulates in Product [ARCHIVED] 12/24/2010
Epogen and Procrit (epoetin alfa): Recall - Particulate Matter in Vials [ARCHIVED] 09/24/2010
Erythropoiesis-Stimulating Agents (ESAs): Procrit, Epogen and Aranesp: Drug Safety Communication [ARCHIVED] 02/16/2010
Evamist (estradiol transdermal spray): Drug Safety Communication - Unintended Exposure of Children and Pets to Topical Estrogen [ARCHIVED] 07/29/2010
Exjade (deferasirox): Boxed Warning [ARCHIVED] 02/18/2010
Fentanyl Transdermal System: Recall - Potential for Active Ingredient to Release Faster Than Specified [ARCHIVED] 11/05/2010
Gadolinium-based Contrast Agents: Class Labeling Change - Risk of Nephrogenic Systemic Fibrosis [ARCHIVED] 09/09/2010
GnRH Agonists: Label Change - Increased Risk of Diabetes and Cardiovascular Disease (Update) [ARCHIVED] 10/20/2010
GnRH Agonists: Safety Review of Drug Class Used to Treat Prostate Cancer [ARCHIVED] 05/03/2010
Heparin Sodium (B. Braun): Recall - Trace Contaminant [ARCHIVED] 10/29/2010
Heparin: Change in Reference Standard [ARCHIVED] 04/07/2010
Hospira Brand Liposyn and Propofol: Recall [ARCHIVED] 06/10/2010
Hyland’s Teething Tablets: Recall - Risk of Harm to Children [ARCHIVED] 10/24/2010
Hylenex recombinant (hyaluronidase human injection): Recall [ARCHIVED] 05/26/2010
Intravenous Medications Manufactured by Claris: Recall due to contamination of products [ARCHIVED] 05/29/2010
Invirase (saquinavir): Label Change - Risk of Abnormal Heart Rhythm [ARCHIVED] 10/21/2010
Invirase (saquinavir): Ongoing safety review of clinical trial data [ARCHIVED] 02/23/2010
Lamictal (lamotrigine): Label Change - Risk of Aseptic Meningitis [ARCHIVED] 08/12/2010
Lipitor (atorvastatin) 40 mg: Recall Specific Bottles [ARCHIVED] 12/23/2010
Long-Acting Beta-Agonists (LABAs): New Safe Use Requirements [ARCHIVED] 04/15/2011
Maalox Total Relief and Maalox Liquid Products: Medication Use Errors [ARCHIVED] 02/17/2010
McNeil Consumer Healthcare Over-the-Counter Infants’ and Children’s Products: Recall [ARCHIVED] 04/30/2010
McNeil Consumer Healthcare Over-The-Counter Products: Recall [ARCHIVED] 07/08/2010
Meridia (sibutramine): Market Withdrawal Due to Risk of Serious Cardiovascular Events [ARCHIVED] 10/08/2010
Meridia (sibutramine hydrochloride): Follow-Up to an Early Communication about an Ongoing Safety Review [ARCHIVED] 01/21/2010
Methotrexate Injection, 50mg/2mL and 250mg/10mL Vials: Recall - Presence of Glass Particulates [ARCHIVED] 10/29/2010
Metronidazole injection 500 mg / 100 ml: Voluntary recall due to non-sterility [ARCHIVED] 05/17/2010
Midodrine hydrochloride: FDA Proposes Withdrawal of Low Blood Pressure Drug [ARCHIVED] 08/16/2010
Mylotarg (gemtuzumab ozogamicin): Market Withdrawal [ARCHIVED] 06/21/2010
Needleless Pre-filled Glass Syringes: Stakeholder Advisory - Compatibility Problems with Needleless Intravenous Access Systems [ARCHIVED] 05/06/2011
NeoProfen (ibuprofen lysine) Injection: Recall and Shortage - Risk of Particulate Matter [ARCHIVED] 08/02/2010
Nimodipine Oral Capsules: Medication Errors - IV Administration May Result in Death, Serious Harms [ARCHIVED] 08/02/2010
Oral Bisphosphonates: Ongoing Safety Review of Atypical Subtrochanteric Femur Fractures [ARCHIVED] 03/11/2010
Orlistat (marketed as Alli and Xenical): Labeling Change [ARCHIVED] 05/26/2010
PediaCare Children's Products [Blacksmith Brand]: Recall of four products [ARCHIVED] 05/29/2010
Plavix (clopidogrel): Reduced effectiveness in patients who are poor metabolizers of the drug [ARCHIVED] 03/12/2010
Promacta (eltrombopag): Portal Venous System Thromboses in Study of Patients With Chronic Liver Disease [ARCHIVED] 05/12/2010
Propoxyphene: Withdrawal - Risk of Cardiac Toxicity [ARCHIVED] 11/19/2010
Propylthiouracil [ARCHIVED] 04/21/2010
Proton Pump Inhibitors (PPI): Class Labeling Change 05/25/2010
Qualaquin (quinine sulfate): New Risk Evaluation and Mitigation Strategy - Risk of serious hematological reactions 08/04/2010
Rapamune (sirolimus): Drug Monitoring Recommendations 01/11/2010
Recombinant Human Growth Hormone (somatropin): Ongoing Safety Review - Possible Increased Risk of Death 08/04/2011
Reese Pharmaceutical Company OTC Products: Recall - Mislabeled Guaifenesin Tablets [ARCHIVED] 12/13/2010
Rolaids Extra Strength Softchews, Rolaids Extra Strength plus Gas Softchews, Rolaids Multi-Symptom plus Anti-Gas Softchews: Recall - Foreign Materials in Products [ARCHIVED] 12/14/2010
Sodium Bicarbonate Injection, USP, 7.5% and 8.4%, 50 mL Single Dose Vials - Recall Due to Particulates in Some Vials [ARCHIVED] 12/29/2010
Stalevo (entacapone/carbidopa/levodopa): Ongoing Safety Review [ARCHIVED] 03/31/2010
Stalevo(carbidopa/levodopa and entacapone): Ongoing Safety Review: Possible increased cardiovascular risk [ARCHIVED] 08/20/2010
Tamiflu: Counterfeit Product Sold on Internet [ARCHIVED] 06/17/2010
Tessalon (benzonatate): Drug Safety Communication - Potential for Accidental Ingestion by Children [ARCHIVED] 12/14/2010
Tygacil (tigecycline): Label Change - Increased Mortality Risk [ARCHIVED] 09/01/2010
Tylenol 8 Hour Caplets 50 Count: Recall [ARCHIVED] 10/19/2010
Tysabri (natalizumab): Update of Healthcare Professional Information [ARCHIVED] 04/22/2011
Ultram (tramadol hydrochloride), Ultracet (tramadol hydrochloride/acetaminophen): Label Change [ARCHIVED] 05/25/2010
Valcyte (valganciclovir hydrochloride) Label Change: Possible overdose in pediatric patients [ARCHIVED] 09/15/2010
Velcade (bortezomib): Starting Dose Adjustments for Patients with Hepatic Impairment [ARCHIVED] 01/26/2010
Videx/Videx EC (didanosine): Labeling Revision - Risk of Non-Cirrhotic Portal Hypertension [ARCHIVED] 01/29/2010
Vivitrol (naltrexone for extended-release injectable suspension): Medication Guide Required for Patients [ARCHIVED] 05/04/2010
Zocor (simvastatin): increased risk of muscle injury with high doses [ARCHIVED] 03/19/2010
Zyprexa (olanzapine): Use in Adolescents [ARCHIVED] 01/29/2010

Medical Devices

Product NameDate Issued/Updated
6 French Engage Introducer Devices by St. Jude Medical: Recall - Potential for Separation of Shaft From Hub [ARCHIVED] 08/13/2010
Abbott Glucose Test Strips: Recall - False Low Blood Glucose Results [ARCHIVED] 02/15/2011
Abiomed AB5000 Circulatory Support System: Class I Recall [ARCHIVED] 03/10/2010
Air- or Gas-Pressurized Spray Devices: Risk of Air or Gas Embolism [ARCHIVED] 07/09/2010
AngioSculpt "EX" PTCA Scoring Balloon Catheter by AngioScore, Inc.: Recall - Risk of Catheter Separation [ARCHIVED] 09/08/2010
Arrow Intra-Aortic Balloon (IAB) Catheter Products: Class 1 Recall - Catheters Can Become Stuck in the Sheath 01/27/2011
BagEasy Manual Resuscitation Devices by Westmed, Inc.: Class 1 Recall [ARCHIVED] 09/15/2010
Baxter Colleague Infusion Pumps: FDA Ordering Recall [ARCHIVED] 12/01/2010
Baxter HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems: Class I Recall [ARCHIVED] 03/03/2010
Baylis Medical Torflex Transseptal Guiding Sheath: Class I Recall [ARCHIVED] 03/11/2010
BD Q-Syte Luer Access Devices: Recall [ARCHIVED] 02/09/2010
Beckman Coulter UniCel DxC Synchron Clinical System – Ion Selective Electrode Flow Cell: Class I Recall [ARCHIVED] 03/11/2010
Becton, Dickinson (BD) Q-Syte Luer Access Split Septum Device: Class I Recall [ARCHIVED] 03/18/2010
Boston Scientific Implantable Cardioverter Defibrillators: Recall [ARCHIVED] 03/19/2010
Cardiac Science Automated External Defibrillators - Powerheart, Cardiovive, NK, Responder models: Class I Recall [ARCHIVED] 04/27/2010
Cardiac Science Automated External Defibrillators (Powerheart, Cardiovive, CardioLife models): Recall [ARCHIVED] 02/09/2010
CareFusion Corporation Alaris PC Units (Model 8015): Recall - Potential for Delay or Interruption of Therapy [ARCHIVED] 10/15/2010
Cepheid Xpert MRSA/SA Blood Culture Assay for Use with the GeneXpert Dx System: Class I Recall [ARCHIVED] 07/02/2010
Combat Application Tourniquets (C-A-T): Suspected Counterfeit Product [ARCHIVED] 08/09/2010
CONSTELLATION Vision System: Recall [ARCHIVED] 07/20/2010
Cook brand Ciaglia Blue Rhino/Ciaglia Blue Dolphin Percutaneous Tracheostomy Introducer Sets and Trays [ARCHIVED] 08/04/2010
Counterfeit Polypropylene Surgical Mesh: Initial Communication [ARCHIVED] 06/08/2010
Covidien Initiates Voluntary Recall of Certain Shiley™ Tracheostomy Tubes [ARCHIVED] 04/24/2010
Defibtech DBP-2800 Battery Packs used in Lifeline AED and ReviveR AED: Recall [ARCHIVED] 06/09/2010
Ear Candles: Risk of Serious Injuries [ARCHIVED] 02/20/2010
Edwards Lifesciences Aquarius Hemodialysis System: Recall [ARCHIVED] 01/29/2010
Electric Dental Handpieces and Electric Oral Bone-cutting Handpieces: Safety Investigation of Patient Burns [ARCHIVED] 09/24/2010
ev3 Endovascular Inc. Trailblazer Support Catheter: Class I Recall [ARCHIVED] 01/05/2010
ev3 NanoCross .014" OTW PTA Dilatation Catheter: Class I Recall - Potential for cracking or breaking [ARCHIVED] 12/28/2010
Excelsior Medical 5 ml Fill in 6 cc Prefilled Saline Flush Syringes: Recall - Potential Loss of Sterility [ARCHIVED] 10/15/2010
Fingerstick Devices to Obtain Blood Specimens: Initial Communication - Risk of Transmitting Bloodborne Pathogens [ARCHIVED] 08/26/2010
Fresenius Kabi LLC, Red Blood Cell (RBC) Exchange Sets used on AS104 Blood Cell Separation Devices: Class I Recall [ARCHIVED] 12/21/2010
GE Healthcare Aisys and Avance Anesthesia Systems: Recall [ARCHIVED] 05/13/2010
Gyrus ACMI Micron Bobbin Vent Tube T: Class I Recall [ARCHIVED] 03/17/2010
Hettich Centrifuges with 2050 and 2076 Plastic Rotors: Recall [ARCHIVED] 01/28/2010
HiRes 90K Cochlear Implant Device: Recall - Malfunction [ARCHIVED] 11/27/2010
Hospira Symbiq One-Channel and Two-Channel Infusers: Class I Recall - Motor Encoder Failures [ARCHIVED] 11/04/2010
Hospira Symbiq One-Channel and Two-Channel Infusers: Class I Recall [ARCHIVED] 09/10/2010
Huber Needles: Recall - Risk of Coring [ARCHIVED] 10/12/2010
Infant Sleep Positioners: Consumer Warning - Risk of Suffocation [ARCHIVED] 09/29/2010
Inferior Vena Cava (IVC) Filters: Initial Communication: Risk of Adverse Events with Long Term Use [ARCHIVED] 08/09/2010
Infusion Set Needles [Manufactured by Nipro for Exelint]: Recall [ARCHIVED] 01/26/2010
INOMAX DS Drug-Delivery System: Class I Recall - Risk of Interruption of Drug Flow [ARCHIVED] 08/23/2010
LIFEPAK 15 Monitor/Defibrillator by Physio-Control Inc. [ARCHIVED] 04/22/2010
LIFEPAK 20 and LIFEPAK 20e External Defibrillator/Monitors by Physio-Control Inc.: Class I Recall Due To Power Supply Failure [ARCHIVED] 07/02/2010
Nipro GlucoPro Insulin Syringes: Recall [ARCHIVED] 01/22/2010
Micromedics, Inc. Surgical Sealant Dispensers, Nasal Septal Buttons, and Otological Ventilation Tubes: Class 1 Recall-Weak or Open Seals [ARCHIVED] 11/23/2010
Octopus Nuvo Tissue Stabilizer: Class I Recall - Potential for Device Fracture [ARCHIVED] 11/01/2010
OneTouch SureStep Test Strips (LifeScan): Recall [ARCHIVED] 02/26/2010
Penumbra System Reperfusion Catheter 032: Class I Recall Due to Manufacturing Error [ARCHIVED] 12/08/2010
Safesheath CSG Coronary Sinus Guide Hemostatic Introducer System with Infusion Sideport by Thomas Medical [ARCHIVED] 02/04/2010
Sigma Spectrum Infusion Pump Model 35700: Class 1 Recall: Risk of Over-Infusion [ARCHIVED] 06/15/2012
StatSpin Express 4 Centrifuges Model 510: Class I Recall [ARCHIVED] 02/26/2010
Teleflex Arrow IV Tubing Sets, Accessories, and Embolectomy Catheters: Recall [ARCHIVED] 04/08/2010
Teleflex Medical AQUA+FLEX Hygroscopic Condenser Humidifier (Catalog Number 1570): Recall [ARCHIVED] 05/06/2010
Thomas Medical Products, Inc., Transseptal Sheath Introducer Kits: Class I Recall [ARCHIVED] 03/05/2010
Triton Pole Mount Infusion Pump by WalkMed: Recall - Potential Door Open Alarm Problem [ARCHIVED] 11/30/2010
VITEK 2 Gram Negative Susceptibility Cards Containing Piperacillin/Tazobactam (TZP): Recall - Incorrect Test Results Observed [ARCHIVED] 11/10/2010

Special Nutritional and Cosmetic Products

Product NameDate Issued/Updated
HAPPYTOT Stage 4 and HAPPYBABY Stage 1 & Stage 2 Pouch Meals - Recall [ARCHIVED] 01/13/2010
Miracle Mineral Solution (MMS): Product as consumed produces a potent bleach [ARCHIVED] 07/30/2010
Similac Powder Infant Formulas: Recall [ARCHIVED] 09/24/2010
Vita Breath Dietary Supplement [ARCHIVED] 05/03/2010
Vitamin D Supplement Products: Medication Use Error [ARCHIVED] 06/15/2010

Biologics

Product NameDate Issued/Updated
Afluria (CSL Ltd.) Influenza Virus Vaccine: Label Change - Risk of Fever and Febrile Seizure [ARCHIVED] 07/30/2010
GammaGard Liquid, Immune Globulin Intravenous (Human) [ARCHIVED] 06/04/2010
Octagam (Immune Globulin Intravenous (human)) 5% Liquid Preparation: Market Withdrawal - Risk of Thromboembolic Events [ARCHIVED] 09/24/2010
Rotarix Vaccine: Update to Clinicians and Public Health Professionals [ARCHIVED] 05/16/2010
WinRho SDF (Rho(D) Immune Globulin Intravenous (Human): Risk of Intravascular Hemolysis [ARCHIVED] 03/10/2010

Products With Undeclared Drug Ingredients

Products marketed as dietary supplements, but containing one or more unlisted drug ingredients.

Product NameDate Issued/Updated
Atlas Operations, Inc.: Recall of Sexual Enhancement Products [ARCHIVED] 04/14/2010
Duro Extend Capsules for Men: Recall - Undeclared Drug Ingredient [ARCHIVED] 12/06/2010
Fruta Planta: Public Notification - Undeclared Drug Ingredient 01/03/2011
Joyful Slim Herb Supplement : Recall-Undeclared Drug Ingredient [ARCHIVED] 07/22/2010
Magic Power Coffee: Undeclared Drug Ingredient [ARCHIVED] 06/21/2010
Man Up Now Capsules: Consumer Warning - Undeclared Drug Ingredient [ARCHIVED] 12/13/2010
MasXtreme Capsules (Natural Wellness) - product contains undeclared drug ingredient [ARCHIVED] 08/25/2010
Mr. Magic Male Enhancer: Undeclared Drug Ingredient [ARCHIVED] 08/24/2010
MuscleMaster.com Products Sold on Internet as Dietary Supplements: Recall [ARCHIVED] 01/15/2010
Novacare LLC Products: Recall - Undeclared Drug Ingredient [ARCHIVED] 08/11/2010
Nutraloid Labs ejaculoid XXTREME and stimuloid II: Undeclared Drug Ingredient [ARCHIVED] 07/30/2010
Prolatis’: Undeclared Drug Ingredient [ARCHIVED] 08/13/2010
Que She Herbal Supplement: Undeclared Drug Ingredients [ARCHIVED] 07/08/2010
Revivexxx Extra Strength: Recall - Undeclared Drug Ingredient [ARCHIVED] 08/09/2010
Rock Hard Extreme and Passion Coffee by Drive Total Energy: Recall - Undeclared Drug Ingredient 01/03/2011
RockHard Weekend, Pandora: Recall - Undeclared Drug Ingredient [ARCHIVED] 12/23/2010
Slim- 30 Herb Supplement: Undeclared Drug Ingredient [ARCHIVED] 07/19/2010
Slimming Beauty Bitter Orange Slimming Capsules: Undeclared Drug Ingredient [ARCHIVED] 10/08/2010
Solo Slim, Solo Slim Extra Strength: Recall - Undeclared Drug Ingredient [ARCHIVED] 08/09/2010
Stud Capsule For Men: Product contains Undeclared Drug Ingredient [ARCHIVED] 04/06/2010
TimeOut Capsules: Undeclared Drug Ingredient [ARCHIVED] 08/25/2010
Vialipro Dietary Supplement: Recall-Undeclared Drug Ingredient [ARCHIVED] 07/20/2010
Vigor-25: Undeclared Drug Ingredient-Sold as natural dietary supplement [ARCHIVED] 11/19/2010

Page Last Updated: 12/30/2014
Note: If you need help accessing information in different file formats, see Instructions for Downloading Viewers and Players.