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 In this section:

                Safety & Availability (Biologics)

Safety & Availability (Biologics)

                        Biologic Product Security
          Blood Safety & Availability
          CBER-Regulated Products: Shortages and Discontinuations
          Pandemics & Emerging Diseases
          Tissue Safety & Availability
          Vaccine Safety & Availability


                        HIV Home Test Kits
          Recalls (Biologics)
          Report a Problem to the Center for Biologics Evaluation & Research Home
          Vaccines, Blood & Biologics
          Safety & Availability (Biologics)
          2023 Safety and Availability CommunicationsSafety & Availability (Biologics) 2023 Safety and Availability Communications
  
  	
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November 2023

FDA Investigating Serious Risk of T-cell Malignancy Following BCMA-Directed or CD19-Directed Autologous Chimeric Antigen Receptor (CAR) T cell Immunotherapies
	November 28, 2023
	Important Information About the Correct Dosage and Administration of Moderna COVID-19 Vaccine (2023-2024 Formula) for Individuals 6 Months Through 11 Years of Age
	November 1, 2023October 2023

Important Information About Directed Blood Donations that are Not Medically Indicated
	October 23, 2023September 2023

Dear Healthcare Provider Letter - Warning Regarding Use of Probiotics In Preterm Infants
	September 29, 2023
	Voluntary Lot Withdrawal of Allergenic Extract – Pecan nut (*Carya illinoinensis*) – For Diagnostic Use Only, Manufactured by ALK-Abelló, Inc. for Increased Reports of False Negative Test Results
	September 22, 2023
	Important Information for Human Cell, Tissue and Cellular and Tissue-based Product (HCT/P) Establishments Regarding Tuberculosis Outbreaks Linked to a Bone Matrix Product
	September 6, 2023April 2023

Public Safety Notification on Amniotic Fluid Eyedrops
	April 10, 2023March 2023

FDA Requires Warning about Anaphylaxis Following False Negative Food Allergen Skin Test Results in the Prescribing Information for All Allergenic Extracts for Diagnosis of Food Allergy
	March 3, 2023February 2023

Extension of the Expiration Date for MICRhoGAM Ultra-Filtered PLUS [Rho(D) Immune Globulin (Human)] Lot MG21O04 from 24 months to 36 months (28 JAN 2023, to 28 JAN 2024)January 2023

January 12, 2023 Safety Labeling Change Notification Letter, Allergy Laboratories, Inc. - Non-standardized Allergenics
	January 12, 2023 Safety Labeling Change Notification Letter, ALK-Abello, Inc. - Non-standardized Allergenics
	January 12, 2023 Safety Labeling Change Notification Letter, Greer Laboratories, Inc. - Non-standardized Allergenics

                                                                                  Content current as of:
      11/28/2023Safety & Availability (Biologics)

          
                        Biologic Product Security
          Blood Safety & Availability
          CBER-Regulated Products: Shortages and Discontinuations
          Pandemics & Emerging Diseases
          Tissue Safety & Availability
          Vaccine Safety & Availability


                        HIV Home Test Kits
          Recalls (Biologics)
          Report a Problem to the Center for Biologics Evaluation & Research
 
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