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Safety

2009 Safety Alerts for Human Medical Products

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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, May 29 - Dec 31, 2009

Drugs and Therapeutic Biological Products

Product NameDate Issued/Updated
Albuterol Sulfate Inhalation Solution unit-dose vials (Dey LP brand) [ARCHIVED] 09/10/2009
Alka-Seltzer Plus Day & Night Cold Formula Liquid Gels - Incorrect Packaging [ARCHIVED] 12/09/2009
Atlas Operations, Inc.: Recall of Sexual Enhancement Products [ARCHIVED] 04/14/2010
Dietary Supplements Sold on Internet by Bodybuilding.com [ARCHIVED] 11/03/2009
Body Building Products (Marketed as Containing Steroids or Steroid-like Substances) [ARCHIVED] 07/28/2009
Botox and Botox Cosmetic (Botulinum toxin Type A) and Myobloc (Botulinum toxin Type B) [ARCHIVED] 04/30/2009
Byetta (exenatide) - Renal Failure [ARCHIVED] 11/02/2009
Cefepime (marketed as Maxipime) Update of Ongoing Safety Review [ARCHIVED] 06/17/2009
Ceftriaxone (marketed as Rocephin and generics) [ARCHIVED] 04/14/2009
CellCept (mycophenolate mofetil) August 2009 [ARCHIVED] 08/14/2009
CellCept (mycophenolate mofetil) and Myfortic (mycophenolic acid) [ARCHIVED] 02/12/2009
Children's and Infants' Tylenol Oral Suspension Products - Recall [ARCHIVED] 09/25/2009
Cleviprex (clevidipine butyrate): Recall [ARCHIVED] 03/17/2010
Clopidogrel (marketed as Plavix) and Omeprazole (marketed as Prilosec) - Drug Interaction [ARCHIVED] 11/17/2009
Clopidogrel bisulfate (marketed as Plavix) [ARCHIVED] 01/26/2009
Colchicine (marketed as Colcrys) [ARCHIVED] 07/30/2009
Concentrated Acetaminophen Drops [ARCHIVED] 07/15/2009
Dexferrum (iron dextran injection) - Labeling Change [ARCHIVED] 10/16/2009
Dextroamphetamine, Amphetamine 20mg Tablets [ARCHIVED] 08/14/2009
Dietary Supplements Distributed by Universal ABC Beauty Supply International, Inc. [ARCHIVED] 04/22/2009
Digoxin, USP 0.125 mg, Digoxin, USP 0.25 mg (Caraco brand) [ARCHIVED] 05/12/2009
Ethex Corporation Product Recall [ARCHIVED] 01/27/2009
Exjade (deferasirox) - Early Communication [ARCHIVED] 09/25/2009
Genzyme Products, Marketed as Cerezyme, Fabrayzme, Myozyme, Aldurazyme, and Thyrogen [ARCHIVED] 11/13/2009
Heparin: Change in Reference Standard [ARCHIVED] 04/07/2010
Hospira Brand Propofol and Liposyn Products - Recall [ARCHIVED] 11/09/2009
Ibuprofen (Unapproved) topical drug products [ARCHIVED] 08/21/2009
IDS Sports Dietary Supplements - Recall [ARCHIVED] 11/17/2009
Immunosuppressant Drugs: Required Labeling Changes [ARCHIVED] 07/14/2009
Influend Cough and Cold Products [ARCHIVED] 04/16/2009
Insulin Pens: Risk of Transmission of Blood-borne Pathogens from Shared Use [ARCHIVED] 03/19/2009
Intelence (etravirine) [ARCHIVED] 08/27/2009
Ketorolac Tromethamine Injection, USP 30 mg/mL; 1mL and 2mL Single Dose Vials -- Recall [ARCHIVED] 11/03/2009
Lantus (insulin glargine) [ARCHIVED] 07/01/2009
Leukotriene Inhibitors: Montelukast (marketed as Singulair), Zafirlukast (marketed as Accolate), and Zileuton (marketed as Zyflo and Zyflo CR) [ARCHIVED] 08/28/2009
Levemir Insulin (Novo Nordisk) [ARCHIVED] 08/26/2009
Lexiva (fosamprenavir calcium) - Dear Healthcare Professional Letter [ARCHIVED] 12/03/2009
Libimax [ARCHIVED] 04/29/2009
Libipower Plus [ARCHIVED] 07/14/2009
Local Anesthetics, Continuously Infused (marketed as bupivacaine, chlorprocaine, lidocaine, mepivacaine, procaine, ropivacaine) - Chondrolysis [ARCHIVED] 11/13/2009
Mallinckrodt Sodium Chromate Cr-51 Injection [ARCHIVED] 07/10/2009
Meridia (sibutramine hydrochloride): Early Communication about an Ongoing Safety Review [ARCHIVED] 11/20/2009
Metoclopramide-Containing Drugs [ARCHIVED] 02/26/2009
Myfortic (mycophenolic acid) [ARCHIVED] 09/03/2009
Natalizumab (marketed as Tysabri) [ARCHIVED] 09/17/2009
Nature & Health Co. supplement products: LibieXtreme, Y-4ever, Libimax X Liquid, Powermania Liquid and Capsule, Herbal Disiac [ARCHIVED] 07/16/2009
Norpramin (desipramine hydrochloride) - Dear Healthcare Professional Letter [ARCHIVED] 12/02/2009
Omalizumab (marketed as Xolair) - Early Communication about an Ongoing Safety Review [ARCHIVED] 07/16/2009
Orlistat (marketed as Alli and Xenical): Early Communication about an Ongoing Safety Review [ARCHIVED] 08/24/2009
Pai You Guo, Marketed as Dietary Supplement - Recall [ARCHIVED] 11/13/2009
Peramivir IV [ARCHIVED] 10/24/2009
Promethazine Hydrochloride Injection [ARCHIVED] 09/16/2009
Propafenone HCL Tablets [ARCHIVED] 03/25/2009
Propofol Injectable Emulsion, 10 mg/mL 100 mL vials [ARCHIVED] 07/17/2009
Propoxyphene-containing Products [ARCHIVED] 07/07/2009
Propylthiouracil [ARCHIVED] 04/21/2010
Raptiva (efalizumab) Feb 2009 [ARCHIVED] 02/19/2009
Relenza (zanamivir) Inhalation Powder [ARCHIVED] 10/09/2009
Rituxan (rituximab) - PML [ARCHIVED] 10/23/2009
RockHard Weekend - product contains undeclared drug ingredient [ARCHIVED] 11/18/2009
Simponi (golimumab) [ARCHIVED] 05/28/2009
Sirolimus (marketed as Rapamune) [ARCHIVED] 06/11/2009
Sitagliptin (marketed as Januvia and Janumet) - acute pancreatitis [ARCHIVED] 09/25/2009
Skin Products Made by Clarcon [ARCHIVED] 06/09/2009
Stamina-Rx Dietary Supplement Products [ARCHIVED] 06/19/2009
Stiff Nights - product contains undeclared drug ingredient [ARCHIVED] 11/05/2009
Stimulant Medications used in Children with Attention-Deficit/Hyperactivity Disorder - Communication about an Ongoing Safety Review [ARCHIVED] 12/12/2009
Steam Dietary Supplement [ARCHIVED] 08/24/2009
Tamiflu (oseltamivir) for Oral Suspension [ARCHIVED] 10/16/2009
Tarceva (erlotinib) May 2009 [ARCHIVED] 05/08/2009
Testosterone gel products (AndroGel 1% and Testim 1% ) [ARCHIVED] 05/07/2009
Topical Anesthetics [ARCHIVED] 01/16/2009
Tumor Necrosis Factor (TNF) Blockers (marketed as Remicade, Enbrel, Humira, Cimzia, and Simponi) August 2009 [ARCHIVED] 08/31/2009
Tylenol Arthritis Pain Caplet, 100 count bottles: Recall of all lots [ARCHIVED] 01/15/2010
Valproate Sodium and related products (valproic acid and divalproex sodium): Risk of Birth Defects [ARCHIVED] 12/03/2009
Varenicline (marketed as Chantix) and Bupropion (marketed as Zyban, Wellbutrin, and generics) [ARCHIVED] 07/01/2009
Venom HYPERDRIVE 3.0 [ARCHIVED] 01/27/2009
Vicks Sinex Nasal Spray - Recall [ARCHIVED] 11/19/2009
Voltaren Gel (diclofenac sodium topical gel) 1% - Hepatic Effects Labeling Changes [ARCHIVED] 12/04/2009
Weight Loss Products by Young You Corporation [ARCHIVED] 07/17/2009
Xigris (Drotrecogin alfa [activated]) - Early Communication about an Ongoing Safety Review [ARCHIVED] 02/04/2009
Zencore Plus [ARCHIVED] 03/20/2009
Zicam Cold Remedy Nasal Products (Cold Remedy Nasal Gel, Cold Remedy Nasal Swabs, and Cold Remedy Swabs, Kids Size) [ARCHIVED] 06/16/2009
Zonisamide (marketed as Zonegran, and generics) [ARCHIVED] 02/23/2009

Medical Devices

Product NameDate Issued/Updated
Accusure Insulin Syringes (Qualitest Pharmaceuticals) - Recall [ARCHIVED] 10/27/2009
Accusure Insulin Syringes [31G, 1/2 cc and 1 cc] [ARCHIVED] 08/24/2009
Alaris System (Cardinal Health) [ARCHIVED] 08/05/2009
Arrow International 30cc, 40cc and 50cc Intra Aortic Balloon Pump (IAB) Catheters [ARCHIVED] 04/15/2009
Arthroscopic Shavers: Ongoing Safety Review [ARCHIVED] 07/07/2009
Biosite brand Triage Cardiac Panel [ARCHIVED] 05/08/2009
BiPAP Focus Non-Invasive Ventilator System, Respironics California [ARCHIVED] 07/09/2009
Cardiac Science Corp. Powerheart and CardioVive Automated External Defibrillators: Initial Communication [ARCHIVED] 11/19/2009
Cardiovascular Systems ViperSheath Sheath Introducer - Recall [ARCHIVED] 11/17/2009
Centurion Medical Products - Premie Pack and Meconium Pack - Recall [ARCHIVED] 11/04/2009
Colleague Single and Triple Channel Volumetric Infusion Pumps by Baxter [ARCHIVED] 03/12/2009
ConMed Linvatec - Universal Cables and Power Pro Handpieces [ARCHIVED] 09/10/2009
Cordis CROSSOVER Sheath Introducer - Recall [ARCHIVED] 12/23/2009
Covidien Pedi-Cap End-Tidal CO2 Detector [ARCHIVED] 09/10/2009
CT Brain Perfusion Scans Safety Investigation: Initial Notification [ARCHIVED] 12/07/2009
Disetronic Medical Systems Inc. ACCU-CHEK Spirit Insulin Pump [ARCHIVED] 05/01/2009
Edwards Lifesciences CardioVations EndoClamp Aortic Catheter - Class 1 Recall [ARCHIVED] 11/09/2009
Electronic Cigarettes [ARCHIVED] 07/22/2009
External Biphasic Defibrillators Energy Levels: Initial Communication [ARCHIVED] 11/10/2009
GDH-PQQ (glucose dehydrogenase pyrroloquinoline quinone) Glucose Monitoring Technology [ARCHIVED] 08/13/2009
Hospira, Inc. Device Recall [ARCHIVED] 08/17/2009
LIFEPAK CR Plus Automated External Defibrillators (Physio-Control, Inc) [ARCHIVED] 09/16/2009
Medical Device Power Cords Safety Investigation: Initial Communication [ARCHIVED] 10/19/2009
Medtronic Kappa Series 600/700/900, Sigma Series 100/200/300 Pacemakers [ARCHIVED] 06/11/2009
Medtronic Neurologic Technologies, Innervision Snap Shunt Ventricular Catheter, BioGlide and Snap Shunt Ventricular Catheter, BioGlide [ARCHIVED] 03/27/2009
Medtronic Neuromodulation, INDURA 1P Intrathecal Catheter, Intrathecal Catheter, Sutureless Pump Connector Revision Kit, and Intrathecal Catheter Pump Segment Revision Kit [ARCHIVED] 09/24/2009
Medtronic Paradigm Quick-Set Infusion Sets [ARCHIVED] 07/13/2009
Negative Pressure Wound Therapy (NPWT) systems - Preliminary Public Health Notification [ARCHIVED] 02/28/2011
Neuron 6F 070 Delivery Catheter [Penumbra] [ARCHIVED] 10/01/2009
Nuby Gel Filled, Cottontails, and Playschool Teethers [ARCHIVED] 07/18/2009
Penumbra Neuron 5F Select Catheter [ARCHIVED] 09/09/2009
Philips Avalon Fetal Monitors [ARCHIVED] 09/04/2009
Philips Heartstart Fr2+ Automated External Defibrillators - Recall [ARCHIVED] 10/05/2009
Pointe Scientific Liquid Glucose Hexokinase Reagent - Recall [ARCHIVED] 10/30/2009
Portex Uncuffed Pediatric-Sized Tracheal Tubes (sizes 2.5, 3.0 and 3.5 mm) [ARCHIVED] 09/21/2009
POWERSAIL Coronary Dilatation Catheters [ARCHIVED] 07/30/2009
Respironics, Inc. SmartMonitor 2 Infant Apnea Monitor, Models 4002 and 4003 [ARCHIVED] 05/18/2009
Shiley 3.0PED Cuffless Pediatric Tracheostomy Tube by Covidien Inc. [ARCHIVED] 03/10/2009
Stabilet Infant Warmer models 200, 300, 1250, 1500, 200/3000, 2000, 2200/3200, 3000, and 3200 [Dräeger/Hill-Rom] [ARCHIVED] 08/25/2009
Steris System 1 Processor: FDA Notice and Recommendations [ARCHIVED] 12/17/2009
Stryker Operating Room System II Surgical Navigation System - Recall [ARCHIVED] 11/27/2009
Synthes USA, Ti Synex II Vertebral Body Replacement - Class I Recall [ARCHIVED] 11/12/2009
Thermoflect Blankets and product line - Recall [ARCHIVED] 12/28/2009
Tri-State Hospital Supply Corporation, Centurion Brand Trays and Kits [ARCHIVED] 04/03/2009
Unomedical Manual Pulmonary Resuscitator - Recall [ARCHIVED] 11/03/2009
Welch Allyn AED 10 and and MRL JumpStart Defibrillators [ARCHIVED] 03/16/2009
ZOLL AED Plus Defibrillator [ARCHIVED] 04/09/2009

Special Nutritional and Cosmetic Products

Product NameDate Issued/Updated
Fun Express Water-based Face Paints for Children [ARCHIVED] 05/12/2009
Hydroxycut Products [ARCHIVED] 05/01/2009
Neocate Infant Specialized Formula - Recall [ARCHIVED] 09/29/2009
Nestle Toll House Prepackaged, Refrigerated Cookie Dough [ARCHIVED] 06/20/2009
Nzu, Traditional Remedy for Morning Sickness [ARCHIVED] 12/31/2009
Personal Care Non-Acetone Nail Polish Remover [ARCHIVED] 04/29/2009
Stealth Chocolate, Stealth Vanilla Powdered Dietary Supplement: Vital Pharmaceuticals Inc [ARCHIVED] 07/09/2009

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