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

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MMQC-13-2183

Medical Material Quality Control Message

MMQC-13-2183


Message Number: MMQC-13-2183
Released On: 20-DEC-13
Message Class: Unclassified
Material Type: Vaccine
MMQC\MMI Reference:
FDA Recall Reference:
ECRI Reference:
DLA Reference:
MFG Release Date:

Subject:

GARDASIL {Human Papillomavirus Quadrivalent (Types 6,11,16, and 18) Vaccine, Recombinant} / Merck



Reason / Information:

Merck has issued a voluntary recall on the following medical materiel. Reason: potential for a limited number of vials to contain glass particles.


Disposition / Instructions:

A medical assessment conducted by Merck concluded that if a vaccine containing glass particles is administered to a patient, there is a remote risk of an injection site reaction. The sterility of the vaccine has not been impacted. If product from this lot has been administered, revaccination is not necessary. The supply of Gardasil will not be impacted by this recall. To obtain return instructions, call Stericycle, Inc. at 855-741-4996 or 317-860-1188. Medical questions call 800-672-6372; prompt #2 then prompt #3 or 908-423-1000.



Note: This lot was distributed between 20 August 2013 and 09 October 2013.


Item Information:

NSN (FSC-NIIN): 6505 - 016039115
NDC: 00006-4045-41
Nomenclature: GARDASIL, HUMAN PAPILLOMAVIRUS VACCINE, 0.5ML VIAL, 10S
UI: PG
Manufacturer: MERCK
Distributor:

LOT / SN:
J007354


NSN (FSC-NIIN): 6505 - NS1
NDC: 00006-4045-01
Nomenclature: GARDASIL, HUMAN PAPILLOMAVIRUS VACCINE, VIAL 0.5ML
UI: VI
Manufacturer: MERCK
Distributor:

LOT / SN:
J007354


Service/Additional Instructions:

Recall to Retail Level


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@us.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


Additional Message Recipients:

Please ensure dissemination of this information to the following:

Command Channels
Immunization Clinics
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 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: 08/01/2014