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U.S. Army Medical Materiel Agency
(USAMMA)

 MMQC / MMI Message Search

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1 message found.


Medical Material Quality Control Message

MMQC-18-2189


Message Number: MMQC-18-2189
Released On: 29-Aug-18
Message Class: Unclassified
Material Type: Vaccine
MMQC\MMI Reference:
FDA Recall Reference:
ECRI Reference: P4902 / 01
DLA Reference: 18-477
MFG Release Date: 06-Jul-2018

Subject:

GARDASIL 9 Prefilled Syringes


Reason / Information:

Normal Priority / Pharmaceutical / ECRI: P4902 / 01 / Merck issued a Voluntary Recall on the following product(s). Reason: May Be Labeled with Incorrect Lot Number and Expiration Date. **Identify any affected product in inventory**


Disposition / Instructions:

Action Needed:

1. Examine your inventory and quarantine all GARDAS1L9 vaccine cartons and pre-filled syringes labeled as belonging to Lot N029069 (Expiration 17MAY2020) or Lot M743R56 (Expiration 01/02/03).

--Once quarantined, product should be returned according to the procedure described below.

--If you have further distributed material printed with either Lot N029069 (Expiration 17MAY2020) or Lot M743R56 (Expiration 01/02/03), conduct a sub-recall and notify your direct customers of this product recall (see step 6).

2. Complete the enclosed postage-paid business reply card and packing slip. Be sure to indicate the number of cartons and/or pre-filled syringes you have returned or will be returning.

3. Complete and return the enclosed business reply card as soon as possible.

4. Return a copy of the business reply card, even if you do not have any of the product subject to this recall, so that we can be sure to account for all product distributed.

5. Return the shipping label and all of the product subject to this recall that is in your inventory, using the prepaid shipping labels, to:

Stericycle, Inc.
Attn: Event 8425
2670 Executive Drive, Suite A
Indianapolis, IN 46241

If you require additional prepaid shipping labels, packing slips or business reply cards, contact Stericycle, Inc.

6. If you have further distributed material printed with either Lot N029069 (Expiration 17MAY2020) or Lot M743R56 (Expiration 01/02/03)

--Notify customers to whom you distributed such product by sending them copies of the following:

------this "Dear Customer Letter" and
------the enclosed Notification of Vaccine Recall

--Instruct customers to contact Stericycle, Inc., at 877-643-8438, for product return instructions. Stericycle, Inc. will provide all customers with prepaid shipping labels, packing slips and business reply cards.

Complete and return the enclosed business reply card as soon as possible.

For questions about the recall process (including how to return the recalled product), contact:

--Stericycle, Inc.: 877-643-8438

Customers will be reimbursed for returned product at the price applicable to each customer at the time of purchase.

Customers will be reimbursed for product returned under this recall in the form of a credit or a check, subject to Merck's discretion.

For Further Information:

Merck National Service Center
Tel.: (800) 672-6372 Select Prompt #1 then Prompt #2 (Monday to Friday 8:00 AM to 7:00 PM EST)

Note: See Image on Message under Additional Documentation/Attachment for enclosed referenced document(s) and manufacturer letter.


Item Information:

NSN (FSC-NIIN): 6505 - NS1
NDC: 00006412102
UPC: 30006412102
Nomenclature: GARDASIL 9 SYRINGE 0.5ML
UI: CS
Manufacturer: MERCK
Distributor: AMERISOURCEBERGEN/MCKESSON

LOT / SN:
M743R56 N029069


NOTE 1:
See Image on Message under Additional Documentation/Attachment for Lot Number(s) Expiration Date.


NSN (FSC-NIIN): 6505 - NS2
NDC: 00006412101
Nomenclature: GARDASIL 9 SYRINGE 0.5ML
UI: CS
Manufacturer: MERCK
Distributor: MCKESSON

LOT / SN:
M743R56 N029069


NOTE 1:
See Image on Message under Additional Documentation/Attachment for Lot Number(s) Expiration Date.


Service/Additional Instructions:


Recall to Retail Level


POC Contact Information:

US AIR FORCE
Email: usaf.detrick.afmoa.mbx.sgmp-scs-alerts@mail.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): 301-619-4198
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

Message Dissemination Authorization

AF Activities Will Take Action As Prescribed In AFI 41-209, Medical Logistics Support, Chapter 3. For MACOMS & 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 ***