2023 Safety and Availability Communications
This webpage was developed to provide the public with important information about the safety and availability of biological products.
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, 2023
October 2023
- Important Information About Directed Blood Donations that are Not Medically Indicated
October 23, 2023
September 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, 2023
April 2023
- Public Safety Notification on Amniotic Fluid Eyedrops
April 10, 2023
March 2023
February 2023
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