Safety Information FDA MedWatch   |   Recalls / Withdrawals   |   FDA Patient Safety News   |   Counterfeit Initiative 2004 | 2003 | 2002 | 2001 | 2000 | 1999 2004 Notification Regarding Platelets, Pheresis Collection Using the Gambro Trima Accel Automated Blood Collection System - Gambro BCT, Inc - 7/23/2004 Notice to Readers: Manufacturer's Recall of Human Rabies Vaccine - MMWR - 4/2/2004   2003 Antibody to HBsAg ELISA Test System 3 (Ortho-Clinical Diagnostics Inc) - Increased reactive rate and false repeat reactive rate - MedWatch - 12/23/2003 Update on Particulate Matter in Blood Bags - 10/31/2003 FDA Announces Initiative to Heighten Battle Against Counterfeit Drugs - 7/16/2003 Women with Smallpox Vaccine Exposure During Pregnancy Reported to the National Smallpox Vaccine in Pregnancy Registry --- United States, 2003 - MMWR - 5/2/2003 FDA Current Thinking on Irradiating and/or Freezing Blood Components Collected and Stored in Anticoagulant/Preservative Solutions Not Specifically Approved for Such Use - 3/5/2003 Frequently Asked Questions on FDA's Continuing Investigation of Particulate Matter in Blood - 2/27/2003 Update on FDA's Continuing Investigation of Particulate Matter in Blood Shows Normal Blood Components and No Evidence for an Increase in Adverse Events - 2/27/2003 Information Alert on Particulate Matter in Blood Bags - 2/7/2003 FDA Recommends Temporary Additional Blood Inspection Measures as it Continues Investigation of Reports of White Particulate Matter in Some Units of Blood and Blood Components - 2/7/2003   2002 Public Health Dispatch: Investigation of Blood Transfusion Recipients with West Nile Virus Infections - MMWR - 9/13/2002 CDC Investigates Possible West Nile Virus Transmission Through Organ Transplant - Press Release - 9/1/2002 Information about West Nile Virus and Blood Safety - 8/17/2002 FDA Interim Statement Regarding Immune Globulin Intravenous (IGIV) - 8/27/2002 CDRH - Public Health Notification: Human Tissue Processed by Cryolife, Inc. - 8/21/2002 (PDF), (Text) FDA Issues Order to Recall and To Prevent Further Use of Human Tissue Processed at Cryolife, Inc. - 8/14/2002 FDA Public Notification: PVC Devices Containing the Plasticizer DEHP - Blood bags and infusion tubing may contain DEHP-plasticized PVC - MedWatch - 7/12/2002 Important New Drug Warning - PLAS+SD (Pooled Plasma), (Human) Solvent Detergent Treated) - 3/29/2002 Immune Globulin Intravenous (Human) - Baxter Healthcare Corp - Serious thrombotic events Post marketing reports describing serious thrombotic events (vascular occlusion) possibly associated with the administration of Immune Globulin Intravenous (Human) (IGIV). Precautionary statements, advising physicians to exercise caution in administering IGIV to patients with cardiovascular disease or previous thrombotic events, have been added to the labeling of both Baxter's Gammagard S/D and American Red Cross' Polygam S/D. The letters remind healthcare professionals of measures that may be important in reducing the risk of a thrombotic event. - MedWatch - 3/26/2002 Important Recall Information Relating to Immune Globulin Intravenous (Human) - (Bayer Corp) - 3/20/2002, Updated 3/21/2002 Recall of Immune Globulin Intravenous (Human) 10% Solvent/Detergent Treated, Gamimune N - (Bayer Corp) - 3/14/2002 Recall of Immune Globulin Intravenous (Human) 10% Solvent/Detergent Treated, Gamimune N - (Bayer Corp) - 2/1/2002 Lymphocyte Immune Therapy (LIT) Letter - 1/30/2002 - (Text), (PDF)     Note: the correct CBER contact telephone number is 301-827-5102 Updated -Transfusion Related Acute Lung Injury Letter - 10/19/2001 - (Text), (PDF)   2001   2000 PLAS+SD (Pooled Plasma, [Human] Solvent Detergent Treated), Important Prescribing Information - MedWatch - 10/20/2000 Murex SUDS HIV-1 (Rapid EIA), Abbott Laboratories, Manufacturing problems related to the failure to meet certain panel and negative control specifications - MedWatch - 10/18/2000 Availability of Abbott / Murex Single Use Diagnostic System (SUDS) HIV-1 Test - 10/18/2000 FDA considers the risk of bacteremia from Red Blood Cell units using Pre-storage Leukocyte Reduction Set for Red Cells filters (Sepacell) to be very low - 9/22/2000 Autologous Cultured Chondrocytes (Carticel), Genzyme Tissue Repair - Notice of Change in Product Labeling - MedWatch - 3/16/2000 Options for Alternative Arm Preparation - Clinipad Recall - 3/9/2000 - Updated 3/28/2000 Recall of Clinipad Sterile Products Used in Prepackaged Procedure Kits and Trays - CDRH Letter - 3/29/2000 Clinipad Recall Further Information - MedWatch - 3/10/2000 FDA Alerts Health Professionals and Consumers to Nationwide Recall of Clinipad Antiseptic Sterile Products - HHS NEWS - 3/10/2000 Recall of Sterile Povidone Iodine, Tincture of Iodine, Benzoin Tincture, Acetone Alcohol, and Alcohol Antiseptic Products as Well as Sterile CliniguardŽ Protective Dressing, and Specified Lots of Nonsterile Products - 3/9/2000 Poliovirus Vaccine Live Oral Trivalent (Orimune) - Change in storage conditions - MedWatch - 2/7/2000 Rho(D) Immune Globulin Intravenous (Human) (WinRho SDF) - Updated prescribing and treatment information: Rho(D) positive patients treated with WinRho SDF should be monitored for signs and/or symptoms of intravascular hemolysis (IVH), clinically compromising anemia, and renal insufficiency - MedWatch - 1/7/2000   1999 Dear Doctor Letter IMPORTANT DRUG WARNING - Potential risk of ACUTE RENAL FAILURE reported to be associated with administration of Immune Globulin Intravenous (Human) - 9/24/1999 - (PDF), (Text) Thimerosal in Vaccines: A Joint Statement of the American Academy of Pediatrics and the Public Health Service - 7/9/1999 False Negative Results With Use of Unapproved HIV Rapid Home-Use Test Kit - EZ MedTest - 7/6/1999 URGENT BIOLOGIC FIELD CORRECTION of Immune Globulin Intravenous (Human) - 7/1/1999 URGENT REQUEST for Product QUARANTINE of Immune Globulin Intravenous (Human), Alpha Therapeutic Corp. - 6/11/1999 Immune Globulin Intravenous (Human) - Associated renal adverse events - Medwatch - 6/25/1999 Albumin (Human) 25% - Medwatch - 3/5/1999 Immune Globulin Intravenous (Human) - Medwatch - 3/5/1999

Updated July 23, 2004

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