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U.S. Army Medical Materiel Agency
(USAMMA)

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1 message found.


Medical Material Quality Control Message

MMQC-19-1082


Message Number: MMQC-19-1082
Released On: 11-Jan-19
Message Class: Informational
Material Type: Vaccine
MMQC\MMI Reference: 19-1050
FDA Recall Reference:
ECRI Reference:
DLA Reference:
MFG Release Date:

Subject:

RESUME USE of BIOTHRAX (ANTHRAX), MDV (10-DOSE) / Joint Vaccine Acquisition Program (JVAP)


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.


Item Information:

NSN (FSC-NIIN): 6505 - 013996828
NDC: 64678021105
Nomenclature: ANTHRAX VACCINE ADSORBED 10 DOSE 5ML VIAL
UI: VI
Manufacturer: EMERGENT BIOSOLUTIONS
Distributor:

LOT / SN:
FAV578A FAV585A


NOTE 1:
LOT#: FAV578A Expiration Date: 27 May 2019, LOT#: FAV585A Expiration Date: 24 June 2019


Service/Additional Instructions:



POC Contact Information:

US AIR FORCE
Email: usaf.detrick.afmoa.mbx.sgmp-scs-alerts@mail.mil
Phone (COMM): 301-619-4183
Phone (DSN): 343-4183
Fax: 301-619-2557

US ARMY
Email: usarmy.detrick.medcom-usamma.mbx.doc@mail.mil
Phone (COMM): 301-619-4198
Phone (DSN): 343-4198
Fax: 301-619-4468

US NAVY
Email: usn.detrick.navmedlogcomftdmd.list.mmqc@mail.mil
Phone (COMM): 301-619-3085
Phone (DSN): 343-3085
Fax: 301-619-2473

USAMMC-E
Email: usarmy.rheinland-pfalz.medcom-usammce.list.dtd-quality-assurance@mail.mil
Phone (COMM): 011-49-6331-86-7118/7181
Phone (DSN): 495-7118
Fax: 6218

USCG
Email: daniel.L.Hasenfang@uscg.mil
Phone (COMM): 757-628-4331
Phone (DSN):
Fax: 757-628-4337

USFK CUST CONTACT USAMMC-K PHARM
Email: usarmy.carroll.medcom-kor.list.usammc-k-customer-support@mail.mil
Phone (COMM): 011-82-54-970-8340
Phone (DSN):
Fax: KOREAN CELL:010-9232-8824

Additional Message Recipients:

Please ensure dissemination of this information to the following:


Message Dissemination Authorization

AF Activities Will Take Action As Prescribed In AFI 41-209, Medical Logistics Support, Chapter 3. For MACOMS & NGB--This Msg Has Been Transmitted To All Designated Subordinate Medical Activities.

See Army Regulation (AR) 40-61, 28 January 2005, Chapter 4, and The Department Of The Army Supply Bulletin (SB 8-75-11) For Applicable Policies and Procedures.

DODD 5105.22 and DODD 6025.13


*** END OF MESSAGE ***