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

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MMQC-14-1736

Medical Material Quality Control Message

MMQC-14-1736


Message Number: MMQC-14-1736
Released On: 19-AUG-14
Message Class: Informational
Material Type: Vaccine
MMQC\MMI Reference:
FDA Recall Reference:
ECRI Reference:
DLA Reference:
MFG Release Date:

Subject:

Influenza Virus Vaccine (AFLURIA) / CSL Behring / bioCSL



Reason / Information:

bioCSL issued Important Prescribing Information on the following product. Reason: An Important Prescribing Information notice dated 31 July 2014 advised of an error in the Highlights Section of the 2014-2015 Prescribing Information (PI) for AFLURIA (Influenza Vaccine). Specifically, the telephone number to report SUSPECTED ADVERSE EVENTS to bioCSL Inc., is incorrect in the package insert that is currently in the packaging of the vaccine.


Disposition / Instructions:

CORRECT TELEPHONE NUMBER for bioCSL Inc. is 844-275-2461. See Image on Message under Additional Documentation/Attachment for the UPDATED Prescribing Information for AFLURIA (Influenza Vaccine).

Additional Suspected Adverse Reactions can also be reported to the Vaccine Adverse Event Reporting System (VAERS) at 800-822-7967 or www.vaers.hhs.gov.

Health care providers and patients are encouraged to report suspected adverse events in patients receiving AFLURIA to bioCSL Inc. or VAERS, and may contact bioCSL medical information department at 844-275-2461 if customers have any questions.


Item Information:

NSN (FSC-NIIN): 6505 - 016272525
NDC: 33332001401
Nomenclature: INFLUENZA VIRUS VACCINEL; USP; TRIVALENT; 0.5ML SINGLE DOSE PREFILLED SYRINGE; AFLURIA
UI: PG
Manufacturer: BIOCSL
Distributor:

LOT / SN:
ALL LOTS
NOTE 1:
All Lots - Expiration Date - 30 Jun 2015.


Service/Additional Instructions:


POC Contact Information:


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
Health Care Providers


Additional Documentation / Attachments

MMQC-14-1736_1.pdf


*** END OF MESSAGE ***
Last Modified Date: 08/01/2014