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
Information Alert on Particulate Matter in Blood Bags - 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 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
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
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
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
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