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

Army Seal Air Force Seal Navy Seal Marine Corp Seal DOD Seal
Q101678
FROM
QUAD SERVICE MMQC FT DETRICK MD//USAMMA/AFMLO/NMLC//
 
***PRIORITY***MESSAGE RELEASED:
11/15/2010
 
****************UNCLASSIFIED****************
 
SUBJ: MMQC-10-1678
ACAMBIS,
INC / SANOFI-PASTEUR BIOLOGICS CO / CENTERS FOR DISEASE CONTROL & PREVENTION (CDC) / DILUENT
LOT # DV01C01 FOR ACAM 2000 SMALLPOX (VACCINIA) VACCINE, LIVE / URGENT PHARMACEUTICAL
NOTIFICATION
 



 
 
 
01. SANOFI-PASTEUR BIOLOGICS (SPB) & CDC ISSUED FIELD ACTION ON
FOL MATL. 
REASON: STABILITY RESULTS REQUIRE FURTHER REVIEW. SPB STATED THAT RESULT 
DOES NOT
POSE "ANY IMMEDIATE RISK TO SAFETY OR EFFICACY OF THE DILUENT". 
ACTION RECOMMENDED: DESTROY
ANY REMAINING DILUENT VIALS WITH LOT # DV01C01 
INCLUDING SMALLPOX VACCINE RECONSTITUTED WITH
SAME DILUENT VIAL LOT. FDA 
DECISION PENDING REGARDING FUTURE USE OF DILUENT VIAL BASED ON
CONCENTRATION OF PRESERVATIVE KNOWN AS PHENOL. DISP: COMPLY W/MFR/DIST 
INSTRS IF RECD.
REPLACEMENT PROVIDED. QUESTIONS, CALL 800-438-8222.

 
NSN:  6505-NS1     UI:  EA
NOM:
DILUENT FOR ACAM 2000 SMALLPOX (VACCINIA); SEE NOTE
MFR:  SANOFI-PASTEUR BIO
LOT/SERIAL
NUMBER(S):
DV01C01                                 
 
02. THE PURPOSE OF THE PHENOL IN THE
DILUENT IS TO IMPART PRESERVATIVE PROPERTIES, 
AND IS NOT NEEDED FOR EFFECTIVE POTENCY OF THE
VACCINE. BASED ON DATA GENERATED 
USING ACAM2000 VACCINE RECONSTITUTED WITH LOW-PHENOL
DILUENT, THERE WAS NO 
LOSS OF PRESERVATIVE EFFECTIVENESS. ALSO, ACAM2000 VACCINE
RECONSTITUTED WITH 
LOW-PHENOL DILUENT MET SPECIFICATIONS FOR VIRAL POTENCY OVER A 5-WEEK
STUDY.

03. MFR WOULD LIKE TO ACKNOWLEDGE THAT THEY HAVE SUBMITTED A BIOLOGICAL PRODUCT
DEVIATION REPORT AND A PRIOR APPROVAL SUPPLEMENT TO THE FDA WITH RESPECT TO 
THE OUT OF
SPECIFICATION RESULT FOR DILUENT LOT DV01C01. 

04. UNITED STATES ARMY MEDICAL MATERIEL
AGENCY DISTRIBUTION OPERATIONS CENTER 
(USAMMA DOC) WILL WORK TO PROVIDE REPLACEMENT DILUENT
WHERE NEEDED. PLEASE 
CONTACT YOUR SERVICE REPRESENTATIVE IMMEDIATELY FOR REPLACEMENT DILUENT.
05. ALL UNOPENED VIALS OF DILUENT LOT NUMBER DV01C01 THAT ARE DESTROYED MUST 
BE REPORTED
TO THE USAMMA DOC. AN EXECUTIVE SUMMARY (EXSUM) IS NOT REQUIRED 
FOR LOT DV01C01. DESTRUCTION
REPORTS SHOULD BE SENT TO THE USAMMA DOC FAX: 
COM: 301-619-4468 OR DSN 343-4468.

NOTE:
ADDITIONAL NOMENCLATURE FOR 6505-NS1: VACCINE, LIVE, 50% (V/V). GLYCERIN 
USP, 0.25% (V/V)
PHENOL USP IN WATER FOR INJECTION USP, IN 3 ML CLEAR GLASS.


 
06. PASS MSG TO MEDICAL LOG
OFCRS, CMD CHANNELS, PHARMACY, MED STAFF, 
SUPPLY OFCRS, AND SUPPORTED ACTYS/CTRS.

07.
AUTHORITY: DODD 5105.22 AND DODD 6025.13. ADDITIONALLY:

A. ARMY: 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.

B. AIR FORCE: 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.
08. SERVICE SPECIFIC POCS ARE AS FOLS (FAX NOS. ARE AVAILABLE 24 HRS);

ARMY: TELEPHONE COM:
301-619-4300, DSN: 343, FAX: 4468, 
E-MAIL:
usarmy.detrick.medcom-usamma.mbx.quad-service-mmqc@mail.mil

ARMY MEMBERS MAY SUBSCRIBE TO
DODMMQC MESSAGES AND MANY OTHER TOPICS AT THE 
FOLLOWING WEBSITE:
HTTP://WWW.USAMMA.ARMY.MIL/ASSETS/APPS/NALA_QAWEB/NALA_INDEX.CFM 
CLICK ON "SUBSCRIBE TO MMQC
MESSAGES HERE."

USAMMCE: TELEPHONE COM: 011-49-6331-86-7118/7181, DSN: 495-7118, FAX: 6218,
E-MAIL: USAMMCE_QA@AMEDD.ARMY.MIL

AIR FORCE: TELEPHONE COM: 301-619-4170, DSN: 343, FAX:
6844, 
E-MAIL: AFMOA.SGALC@DETRICK.AF.MIL

AIR FORCE MEMBERS MAY SUBSCRIBE TO THE DODMMQC
MESSAGES AND MANY OTHER 
TOPICS AT THE FOLLOWING WEBSITE:
HTTPS://MEDLOG.DETRICK.AF.MIL/MLC/SITE_APPS/AFMLO/PRODUCT/CFM/LIST_DODMMQC.CFM. 
GO TO LIST
SERVER AND SELECT THE CATEGORY "DOD MEDICAL MATERIEL QUALITY CONTROL 
(DODMMQC)."

NAVY:
TELEPHONE COM: 301-619-3085, DSN: 343, FAX: 3087, 
EMAIL: MMQC2@MED.NAVY.MIL

NAVY MEMBERS
MAY SUBSCRIBE TO RECEIVE DODMMQC MESSAGES AT HTTP://WWW.USAMMA.ARMY.MIL
CLICK ON "SUBSCRIBE TO
MMQC MESSAGES."
Last Modified Date: 08/01/2014