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Medical Material Quality Control Message

MMQC-19-2541


Message Number: MMQC-19-2541
Released On: 15-Nov-19
Message Class: Informational
Material Type: Vaccine
MMQC\MMI Reference:
FDA Recall Reference:
ECRI Reference:
DLA Reference:
MFG Release Date:

Subject:

VAXCHORA (Cholera Vaccine, Live, Oral) Storage and Handling Update


Reason / Information:

Informational / Vaccine / On 11 November 2019, Emergent Biosolutions will begin shipping a new VAXCHORA product that can no longer be stored in the freezer. The new product will have a new NDC number (70460-004-01) and requires refrigerated storage (2-8 C). See attached for a frequently asked question document from the manufacturer.


Disposition / Instructions:

ACTIONS NEEDED:

Do not move any remaining on hand stock of VAXCHORA with NDC 70460-0001-01 to refrigerated storage.

---Continue to store those doses in the freezer from -25 to -15 degrees Celsius.

New shipments of VAXCHORA with NDC 70460-0004-01 should be refrigerated at 2-8 degrees Celsius.

---There are no other changes to the instructions for reconstitution or administration of the new product.

In the event the new refrigerated product is inadvertently stored in a freezer, move it to refrigerated storage, and contact your logistics service representative for disposition instructions.


Item Information:

NSN (FSC-NIIN): 6505 - NS1
NDC: 70460-0041-01
Nomenclature: VAXCHORA VACCINE 100ML
UI: VI
Manufacturer: PAXVAX
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
Medical Log Officers
Medical Staff
Pharmacy Officers
Supply 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

Additional Documentation / Attachments


*** END OF MESSAGE ***