2004 Safety Alerts for Human Medical Products

-

Drugs and Theraputic Biological Products

Product Name	Date Issued/Updated
Abilify (aripiprazole)	04/12/2004
Amaryl (glimepiride)	10/26/2004
American Health Herbs Ministry Eye Rinse Products	12/29/2004
Bextra (valdecoxib)	12/10/2004
Bicillin C-R (penicillin G benzathine and penicillin G procaine injectable suspension)	11/30/2004
Bicillin L-A (penicillin G benzathine injectable suspension)	11/30/2004
Carbolith (lithium carbonate)	12/09/2004
Celebrex (celecoxib) Dec 2004	12/21/2004
Children's Motrin Grape Chewable Tablets	05/14/2004
Clozaril (clozapine tablets)	04/07/2004
Counterfeit contraceptive patches	02/06/2004
Crestor (rosuvastatin) Jun 2004	06/09/2004
Cytotec Solutions, Inc. Products	04/15/2004
Depo-Provera (medroxyprogesterone acetate injectable suspension)	11/19/2004
Desyrel (trazodone hydrochloride)	05/12/2004
Domperidone	06/10/2004
Duragesic (fentanyl transdermal system) Feb 2004	02/20/2004
Effexor and Effexor XR (venlafaxine HCl)	06/28/2004
Geodon (ziprasidone)	08/31/2004
Levoxyl (levothyroxine sodium)	10/04/2004
Lovenox (enoxaparin sodium injection)	08/17/2004
Major Twice-A-Day 12 Hour Nasal Spray	03/26/2004
Mifeprex (mifepristone) Nov 2004	11/15/2004
Naproxen	12/21/2004
Oral-B CrossAction Power and PowerMAX Toothbrushes and Refills	10/29/2004
OTC pain and fever reducers (acetaminophen / NSAIDs)	01/22/2004
Oxandrin (oxandrolone, USP)	05/05/2004
Paxil (paroxetine hydrochloride)	06/22/2004
Protonix I.V. (pantoprazole sodium)	09/24/2004
Public Health Advisory: Suicidality in Children and Adolescents Being Treated with Anti-depressant Medications	10/15/2004
Public Health Advisory: Antidepressant Use in Children, Adolescents, and Adults	03/22/2004
Public Health Advisory: FDA Recommendations Concerning the Use of NSAIDs	12/27/2004
Remicade (infliximab)	10/13/2004
Reminyl (galantamine hydrobromide) Oct 2004	10/26/2004
Risperdal (risperidone) Aug 2004	08/04/2004
Rituxan (rituximab) Oct 2004	10/08/2004
Seroquel (quetiapine fumarate)	04/08/2004
Serzone (nefazodone hydrochloride)	06/23/2004
Strattera (atomoxetine) Dec 2004	12/21/2004
Vioxx (rofecoxib) Sep 2004	09/30/2004
Viramune (nevirapine) Feb 2004	02/02/2004
Wellbutrin (bupropion hydrochloride), Wellbutrin SR, Wellbutrin XL	06/22/2004
Zelnorm (tegaserod maleate) Apr 2004	04/28/2004
Zometa (zoledronic acid) Injection	09/30/2004
Zyprexa (olanzapine) Mar 2004	03/22/2004

-

Medical Devices

Product Name	Date Issued/Updated
Absorbable Hemostatic Agents	04/02/2004
Access CardioSystems Automated External Defibrillators	11/19/2004
Arjo Alenti Lift Hygiene Chair	07/13/2004
Arjo MINSTREL Patient Lifts	05/27/2004
Bio-Med Patient Tubing Assembly with Adaptor	12/23/2004
Boston Scientific Express2™ (bare metal) Coronary Stent	07/23/2004
Boston Scientific Taxus Coronary Stent	07/13/2004
CARDIAC Reader System	12/14/2004
Carl Zeiss Ophthalmic System	07/13/2004
Faaborg Patient Lifts	03/11/2004
Hospitak Airway Adapter	12/02/2004
Medibo Minerva Patient Lifts	09/03/2004
Medtronic 8870 Software Application Card Version AAA 02	09/24/2004
Medtronic Micro Jewell II Model 7223Cx and GEM DR Model 7271 Implantable Cardioverter Defibrillators	04/20/2004
Nellcor CapnoProbe Sublingual Sensors	09/16/2004
Ortho-Clinical Diagnostics VITROS Troponin I Reagent Pack	07/20/2004
Paradigm Quick-set Plus Insulin Administration Set	05/20/2004
PRECISE RX Nitinol Stent Transhepatic Biliary System	05/12/2004
Pulmonetic Systems LTV Series of Ventilators	09/30/2004
Pulmonetic Systems LTV Series of Ventilators, Universal Cable Adaptor	12/10/2004
Roche Diagnostics Tecan Clinical Workstation	06/09/2004
Roche Molecular Systems COBAS TaqMan and TaqMan 48 Analyzers	07/23/2004
Shiley Tracheosoft XLT Extended Length Tracheostomy Tube and Disposable Inner Cannula	08/09/2004
Tosoh Bioscience AIA-600 II Analyzer	12/03/2004
VITEK GPS-107 (gram positive susceptibility cards)	03/26/2004

-

Biologics

Product Name	Date Issued/Updated
Avastin (bevacizumab) Aug 2004	08/13/2004
Humira (adalimumab) Nov 2004	11/08/2004
Ortho Antibody to HBsAg ELISA Test System 3	01/09/2004
Procrit (epoetin alfa) Dec 2004	12/08/2004
Remicade (infliximab) Aug 2004	08/24/2004
Remicade (infliximab) Dec 2004	12/22/2004

-

Dietary Supplements

Product Name	Date Issued/Updated
Actra-Rx and Yilishen	11/04/2004

-

Safety

Section Contents Menu

2004 Safety Alerts for Human Medical Products

Drugs and Theraputic Biological Products

Medical Devices

Biologics

Dietary Supplements