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Vaccines, Blood & Biologics
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Resources for You
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Safety & Availability (Biologics)
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2009
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2008
- North American Coral Snake Antivenin (Micruris fulvius) (Equine) Lot 4030026 - Extended Dating Period to October 31, 2009
- Information About Heparin and Plasma Derived Products
- Danger Giving Topical Thrombin Intravascularly
- Pregnancy & Lactation Labeling
- FDA's Sentinel Initiative
- Fatal Iatrogenic Hypoglycemia: Falsely Elevated Blood Glucose Readings with a Point-of-Care Meter Due to a Maltose-Containing Intravenous Immune Globulin Product
- Important Safety Information: Dosing and Administration of Immune Globulin (Human), GamaSTANT S/D Packaged in 2-ml Syringes
- Vaccine Safety (CDC)
- Important Safety Information: Dosing and Administration of Rabies Immune Globulin (Human), HyperRAB™ S/D Packaged in 2-ml Syringes
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2007
- 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�)
- PedvaxHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] COMVAX [Haemophilus b Conjugate (Menigococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine
- FDA Statement on Gene Therapy Clinical Trial
- Potential Risk of Variant Creutzfeldt-Jakob Disease (vCJD) From Plasma-Derived Products
- FDA Preliminary Public Health Notification*: Unpredictable Events in Medical Equipment due to New Daylight Saving Time Change
- Advice for Patients: Change in Daylight Saving Time May Affect Your Medical Equipment in an Unpredictable Way
- FDA Public Health Notification: Information on RotaTeq and Intussusception
- Postmarketing Monitoring of Intussusception After RotaTeq™ Vaccination
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2006
- FDA and CDC Update Information on Menactra Meningococcal Vaccine and Guillain Barre Syndrome
- MMWR - Guillain-Barr� Syndrome Among Recipients of Menactra Meningococcal Conjugate Vaccine
- FDA Public Health Notification: Donor Referral Services
- FDA Public Health Notification: Update of Information about BioMedical Tissue Services
- Brief Report: Investigation into Recalled Human Tissue for Transplantation --- United States, 2005 - 2006 (CDC)
- Rho(D) Immune Globulin Intravenous (Human) (WinRho SDF)
- Varicella Zoster Immune Globulin (VZIG) Anticipated Short Supply and Alternate Product Availability Under an Investigational New Drug Application Expanded Access Protocol
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2005
- Important Safety Alert: BacT/ALERT BacT/VIEW Users
- NovoSeven Coagulation Factor VIIa (Recombinant)
- Guillain-Barr� Syndrome Among Recipients of Menactra Meningococcal Conjugate Vaccine - United States, June-July 2005
- FDA and CDC Issue Alert on Menactra Meningococcal Vaccine and Guillain Barre Syndrome
- DIC following Rho(D) Immune Globulin Intravenous Administration
- Disseminated Intravascular Coagulation Associated with Acute Hemoglobinemia or Hemoglobinuria following Rho(D) Immune Globulin Intravenous Administration for Immune Thrombocytopenic Purpura (PDF - 68KB)
- Safety of Albumin Administration in Critically Ill Patients
- Dear Doctor Letter - Albumin Use in Seriously Ill Patients
- Unapproved Home - Use Diagnostic Kits Marketed by Globus Media
- Recall of Rapid HIV Test Kits-Globus Media, Inc
- FDA Warns Consumers Not to Use Home-Use Diagnostic Kits Marketed by Globus Media - Talkpaper
- Important Information Relating to Recall of Fetal Cell Screening Kit (FETALSCREEN) - Ortho-Clinical Diagnostics
- Recall of Fetal Cell Screening Kit (FETALSCREEN) - Ortho-Clinical Diagnostics
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2004
- Potential Hemolysis in Red Blood Cells and Whole Blood (Update)
- Potential Hemolysis in Red Blood Cells Whole Blood
- Increased Rate of Initial and/or Repeat Reactive Results for the Auszyme Monoclonal Test for Hepatitis B Surface Antigen (HBsAg)
- Notification Regarding Platelets, Pheresis Collection Using the Gambro Trima Accel Automated Blood Collection System
- Notice to Readers: Manufacturer's Recall of Human Rabies Vaccine
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2003
- Update on Particulate Matter in Blood Bags
- Women with Smallpox Vaccine Exposure During Pregnancy Reported to the National Smallpox Vaccine in Pregnancy Registry
- FDA Current Thinking on Irradiating and/or Freezing Blood Components Collected and Stored in Anticoagulant/Preservative Solutions Not Specifically Approved for Such Use
- Frequently Asked Questions on FDA's Continuing Investigation of Particulate Matter in Blood
- Information Alert on Particulate Matter in Blood Bags
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Recalls & Alerts
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Key Resources
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Contact Us
- (800) 835-4709
- (301) 827-1800
- ocod@fda.hhs.gov
Consumer Affairs Branch (CBER)
Division of Communication and Consumer Affairs
Office of Communication, Outreach and Development
Food and Drug Administration
1401 Rockville Pike
Suite 200N/HFM-47
Rockville, MD 20852-1448
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