2021 Safety and Availability Communications

This webpage was developed to provide the public with important information about the safety and availability of biological products.

December 2021

• COVID-19 Vaccine Safety Surveillance
  (Updated) December 7, 2021
• Important Information for Blood Establishments and Transfusion Services Regarding Bacterial Contamination of Platelets for Transfusion
  December 2, 2021

September 2021

• Expiration Date Extension for Dextran 40 (10% LMD in 0.9% Sodium Chloride Injection) Lot 07011JT through June 1, 2022
• Expiration Date Extension for Dextran 40 (10% LMD in 5% Dextrose Injection) Lot 09141JT through May 1, 2022 and 12090JT through August 1, 2022

July 2021

• Initial Results of Near Real-Time Safety Monitoring of COVID-19 Vaccines in Persons Aged 65 Years and Older
  July 12, 2021

• FDA Safety Communication: Labeling changes on mortality, kidney injury, and excess bleeding with hydroxyethyl starch products
  July 7, 2021

March 2021

• FDA Requires a Warning about Guillain-Barré Syndrome (GBS) be Included in the Prescribing Information for Shingrix
  March 24, 2021

February 2021

• COVID-19 Vaccine Safety Surveillance
  February 9, 2021

January 2021

• Updated Information for Human Cell, Tissue, or Cellular or Tissue-based Product (HCT/P) Establishments Regarding the COVID-19 Pandemic
  January 4, 2021