Reason / Information:
Informational/This message contains information previously published in MMQC-19-1050, updated to reflected the affected lot, FAV578A and FAV585A, quarantined products may be released from "On Hold" status. It was determined that the pieces of stopper falling into vial upon puncture in a vial of Anthrax Vaccine Adsorbed (AVA) BioThraxTM manufactured by Emergent BioSolutions was due to the use of an incorrect needle size.
Disposition / Instructions:
Actions to be taken:
--Resume use of quarantined lots of BIOTHRAX (ANTHRAX), MDV (10-DOSE) on hands.
--Discard open quarantined vials with possible particulate material visible.
--Use the shortest shelf life products first.
--Ensure when drawing the vaccine that the proper needle is used. Recommended size for intramuscular injection and drawing vaccine from vial is 1 inch, 23 gauge needle. NSN: 6515-01-526-1591
For general questions contact US Army Medical Materiel Agency (USAMMA) Distribution Operations Center (DOC) at 301-619-4318; DSN 343; 301-676-1184, or FAX 310-619-4468.