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Medical Material Quality Control Message

MMQC-19-2533


Message Number: MMQC-19-2533
Released On: 07-Nov-19
Message Class: Informational
Material Type: Vaccine
MMQC\MMI Reference:
FDA Recall Reference:
ECRI Reference:
DLA Reference:
MFG Release Date:

Subject:

BIOTHRAX (ANTHRAX) Beyond-Use Dating


Reason / Information:

Informational / Vaccine / Action Required / Defense Health Agency Immunization Healthcare Division is issuing a new beyond-use labeling guidance. Reason: Change in storage requirements for Biothrax multi-dose vial (MDV)

NOTE: The beyond-use-date refers to the date after which an opened multi-dose vial should not be used, and is written or placed on a multi-dose vial by the individual opening the vial.


Disposition / Instructions:

ACTIONS REQUIRED:

--Immediately begin marking vials of Biothrax with a 28-day beyond-use date at the time of first puncture.

--If the expiration date on the vial is shorter than 28 days from first puncture, mark the beyond-use date as the vial expiration date.

--Discard any open Biothrax vials if an accurate 28-day beyond-use date cannot be established (i.e. the user does not know the exact date the vial was first punctured).

--No revaccination of personnel is required as a result of this new requirement.

--For clinical questions pertaining to this change contact Defense Health Agency Immunization Healthcare at 1-800-GET-VACC (1-877-438-8222) Option 1; DSN 761-4245.


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:
All

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

Additional Message Recipients:

Please ensure dissemination of this information to the following:

Command Channels
Immunization Clinics
Medical Staff
Pharmacy Officers
Supported Activities/Centers
Vaccince Shot Teams

Message Dissemination Authorization

AF Activities will take action as prescribed in AFMAN41-209, Medical Logistics Support, Chapter 7. For MAJCOMS & 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 ***