Safety Information

CBER Recalls / Withdrawals   |   FDA MedWatch   |   FDA Patient Safety News   |   FDA's Sentinel Initiative

2008 | 2007 | 2006 | 2005 | 2004 | 2003

Note: Documents in PDF format require the Adobe Acrobat Reader®. If you experience problems with PDF documents, please download the latest version of the Reader®.


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

Important Safety Information: Dosing and Administration of Immune Globulin (Human), GamaSTANT S/D Packaged in 2-ml Syringes - 3/5/2008

What Clinicians Need to Know About MMRV Vaccine Safety - CDC - 2/27/2008

Important Safety Information: Dosing and Administration of Rabies Immune Globulin (Human), HyperRAB™ S/D Packaged in 2-ml Syringes - 2/22/2008


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

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

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

Safety of Albumin Administration in Critically Ill Patients - 5/16/2005

Unapproved Home-Use Diagnostic Kits Marketed by Globus Media - Medwatch - 2/7/2005

Important Information Relating to Recall of Fetal Cell Screening Kit (FETALSCREEN) - (Ortho-Clinical Diagnostics) - 1/19/2005


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

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

Updated: October 28, 2008