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DOD Medical Materiel Quality Control Messages (MMQC)/Medical Materiel Information Messages (MMI) & Images

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MMQC-13-1662

Medical Material Quality Control Message

MMQC-13-1662


Message Number: MMQC-13-1662
Released On: 17-JUL-13
Message Class: Unclassified
Material Type: Vaccine
MMQC\MMI Reference:
FDA Recall Reference:
ECRI Reference:
DLA Reference: DLA 13-250
MFG Release Date: 03-JUL-2013

Subject:

MENVEO Meningococcal / Novartis Pharmaceuticals / Novartis Vaccines and Diagnostics, Inc.



Reason / Information:

Novartis issued a recall on the following product. Reason: This precautionary and voluntary action is being taken following observation of higher-than-specified levels of residual moisture within the lyophilized MenA component vial in the lot. This residual moisture content is not expected to impact product quality, but constitutes a deviation to registered specifications.


Disposition / Instructions:

Check inventory and follow the steps outlined in the notification. It is important to note that no action is required for patients previously vaccinated with a dose from this lot. For notification letter or questions, call 877-683-4732 or 212-307-1122.


Item Information:

NSN (FSC-NIIN): 6505 - 015825875
NDC: 46028020801
Nomenclature: MENVEO MENINGOCOCCAL (GROUPS A, C, Y AND W-135) OLIGOSACCHARIDE DIPHTHERIA CRM-197 CONJUGATE VACCINE
UI: PG
Manufacturer: NOVARTIS VACCINES AND DIAGNOSTICS
Distributor:

LOT / SN:
M12118 SEE_NOTE_1
NOTE 1:
(Men A vial Lot # A12118 and Men CWY vial lot # X12118)


Service/Additional Instructions:

CONSIGNEES:




POC Contact Information:

NAVY/MARINES:
Email: NMLC.VACCINES@MED.NAVY.MIL
Phone (COMM): 301-619-8054
Phone (DSN): 343-8054
Fax: 301-619-2473

US AIR FORCE:
Email: AFMOA.SGALC@DETRICK.AF.MIL
Phone (COMM): 301-619-4170
Phone (DSN): 343-4170
Fax: 301-619-2557

US ARMY:
Email: usarmy.detrick.medcom-usamma.mbx.doc@mail.mil
Phone (COMM): 301-619-4300
Phone (DSN): 343-4300
Fax: 301-619-4468

USAMMC-E:
Email: USAMMCE_QA@AMEDD.ARMY.MIL
Phone (COMM): 011-49-6331-86-7118/7181
Phone (DSN): 495-7118
Fax: 6218

USFK CUST CONTACT USAMMC-K PHARM:
Email: USAMMCKCUSTSUPPORT@AMEDD.ARMY.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:

Command Channels
Medical Log Officers
Medical Staff
Pharmacy Officers
Supply Officers
Supported Activities/Centers


Message Dissemination Authorization

AF Activities Will Take Action As Prescribed In Afi 41-209, Medical Logistics Support, Chapters 3 And 9. 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 ***
Last Modified Date: 03/18/2014