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                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


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          Vaccines, Blood & Biologics
          Safety & Availability (Biologics)
          2022 Safety and Availability CommunicationsSafety & Availability (Biologics) 2022 Safety and Availability Communications
  
  	
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December 2022

Important Information for Blood Establishments and Transfusion Services Regarding Bacterial Contamination of Platelets for Transfusion
	December 22, 2022
	Voluntary Lot Withdrawals of Allergenic Extract – Peanut (*Arachis hypogaea*)- For Diagnostic Use Only, Manufactured by ALK-Abelló, Inc. for Increased Reports of False Negative Test Results
	December 20, 2022August 2022

Important Information for Human Cell, Tissue, and Cellular and Tissue-based Product (HCT/P) Establishments Regarding Monkeypox Virus and HCT/P Donation
	August 29, 2022
	Safety Alert Regarding Use of Fecal Microbiota for Transplantation and Additional Safety Protections Pertaining to Monkeypox Virus
	August 22, 2022
	Information for Blood Establishments Regarding the Monkeypox Virus and Blood Donation
	August 12, 2022June 2022

Expiration Date Extension for 6 ASCENIV [Immune Globulin Intravenous, Human-slra, 10% Liquid] Lots manufactured in 2019 - 2020May 2022

Expiration Date Extension for 120 BIVIGAM [Immune Globulin Intravenous (Human), 10% Liquid] Lots manufactured in 2020 - 2022March 2022

Voluntary Lot Withdrawals of Immune Globulin Intravenous (IGIV) and Immune Globulin Subcutaneous (IGSC) for Increased Reports of Allergic/Hypersensitivity Reactions
	March 4, 2022January 2022

Updated Information for Blood Establishments Regarding the COVID-19 Pandemic and Blood Donation
	January 11, 2022

                                                                                  Content current as of:
      12/22/2022Safety & 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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