Safety

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2009 Safety Alerts for Human Medical Products

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.

Drugs and Therapeutic Biological Products

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

Medical Devices

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

Special Nutritional and Cosmetic Products

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

Safety

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2009 Safety Alerts for Human Medical Products

Drugs and Therapeutic Biological Products

Medical Devices

Special Nutritional and Cosmetic Products