Safety Information
CBER Recalls / Withdrawals | FDA MedWatch | FDA Patient Safety News | FDA's Sentinel Initiative
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Important Notification: North American Coral Snake Antivenin (Micruris fulvius) (Equine) Lot 4030026 - 10/28/2008
Information About Heparin and Plasma Derived Products - 9/25/2008
Danger Giving Topical Thrombin Intravascularly - 8/2008
Information from CDC and FDA on the Safety of Gardasil Vaccine - 7/22/2008
Pregnancy and Lactation Labeling - 5/28/2008
FDA's Sentinel Initiative - 5/22/2008
Fatal Iatrogenic Hypoglycemia: Falsely Elevated Blood Glucose Readings with a Point-of-Care Meter Due to a Maltose-Containing Intravenous Immune Globulin Product - 4/17/2008
What Clinicians Need to Know About MMRV Vaccine Safety - CDC - 2/27/2008
Interim Recommendations for the Use of Haemophilus influenzae Type b (Hib) Conjugate Vaccines Related to the Recall of Certain Lots of Hib-Containing Vaccines (PedvaxHIB® and Comvax®) - MMWR - 12/19/2007
PedvaxHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] COMVAX [Haemophilus b Conjugate (Menigococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine] - Voluntary Recall - MedWatch - 12/14/2007
FDA Statement on Gene Therapy Clinical Trial - 7/26/2007
Potential Risk of Variant Creutzfeldt-Jakob Disease (vCJD) From Plasma-Derived Products - 3/15/2007
FDA Preliminary Public Health Notification*: Unpredictable Events in Medical Equipment due to New Daylight Savings Time Change - 3/1/2007
FDA Public Health Notification: Information on RotaTeq and Intussusception - 2/13/2007
Statement - FDA and CDC Update Information on Menactra Meningococcal Vaccine and Guillain Barre Syndrome - 10/20/2006
- Update: Guillain-Barré Syndrome Among Recipients of Menactra Meningococcal Conjugate Vaccine --- United States, June 2005--September 2006 - MMWR - 10/20/2006
FEDERAL REGISTER - Extension of Expiration Date for MedWatch (Food and Drug Administration Medical Products Reporting Program) Form - 10/20/2006; Expires May 1, 2007
FDA Public Health Notification: Donor Referral Services - 8/30/2006
FDA Public Health Notification: Update of Information about BioMedical Tissue Services - 3/2/2006
- Brief Report: Investigation into Recalled Human Tissue for Transplantation --- United States, 2005--2006 - MMWR - 5/26/2006
Rho(D) Immune Globulin Intravenous (Human) (WinRho SDF) - Revisions to the WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the prescribing information to address two important safety concerns - MedWatch - 1/6/2006
Important Safety Alert: BacT/ALERT BacT/VIEW Users - Database corruption situation that may lead to a failure to report positive cultures or cause a delay in appropriate patient therapy - (Biomerieux) - 12/16/2005
NovoSeven Coagulation Factor VIIa (Recombinant) - Potential increased risk of thromboembolic adverse events - (Novo Nordisk) - 12/1/2005
Important Safety Information on Interference With Blood Glucose Measurement Following Use of Parenteral Maltose/Parenteral Galactose/Oral Xylose-Containing Products - 11/9/2005
Guillain-Barré Syndrome Among Recipients of Menactra Meningococcal Conjugate Vaccine - United States, June-July 2005 - MMWR - 10/6/2005
FDA and CDC Alert on Menactra Meningococcal Vaccine and Guillain Barre Syndrome - FDA News - 9/30/2005
DIC following Rho(D) Immune Globulin Intravenous Administration - Abstract - 9/1/2005
- Disseminated Intravascular Coagulation Associated with Acute Hemoglobinemia or Hemoglobinuria following Rho(D) Immune Globulin Intravenous Administration for Immune Thrombocytopenic Purpura - Gaines, Ann R., Blood, Vol 106, No 5 - 9/1/2005
Safety of Albumin Administration in Critically Ill Patients - 5/16/2005
Unapproved Home-Use Diagnostic Kits Marketed by Globus Media - Medwatch - 2/7/2005
- Recall of Rapid HIV Test Kits - (Globus Media Inc) - 2/4/2005
- FDA Warns Consumers Not to Use Home-Use Diagnostic Kits Marketed by Globus Media - Talkpaper - 2/7/2005
Important Information Relating to Recall of Fetal Cell Screening Kit (FETALSCREEN) - (Ortho-Clinical Diagnostics) - 1/19/2005
- Recall of Fetal Cell Screening Kit (FETALSCREEN) - (Ortho-Clinical Diagnostics) - 1/8/2005
Potential Hemolysis in Red Blood Cells and Whole Blood Leukocyte Reduced Products Manufactured with the Pall BPF4 Filter (Update) - Pall Medical Corp - 12/17/2004
Potential Hemolysis in Red Blood Cells and Whole Blood Leukocyte Reduced Products Manufactured with the Pall BPF4 Filter - Pall Medical Corp - 12/10/2004
Increased Rate of Initial and/or Repeat Reactive Results for the Auszyme Monoclonal Test for Hepatitis B Surface Antigen (HBsAg) - Abbott Diagnostics, Becton Dickinson - 11/18/2004
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
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
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