Medical Material Quality Control Message
|FDA Recall Reference:
|MFG Release Date:
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.
LOT / SN:
||6505 - 016272525
||INFLUENZA VIRUS VACCINEL; USP; TRIVALENT; 0.5ML SINGLE DOSE PREFILLED SYRINGE; AFLURIA
All Lots - Expiration Date - 30 Jun 2015.
POC Contact Information:
Additional Message Recipients:
Please ensure dissemination of this information to the following:
Medical Log Officers
Vaccince Shot Teams
Health Care Providers
Additional Documentation / Attachments
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