Vaccines, Blood & Biologics

Recall of FLULAVAL QUADRIVALENT

DATE RECALL INITIATED:
April 14, 2015

PRODUCT/ LOT NUMBER:

Product Description Carton NDC Syringe NDC Lot Number Exp Date
FLULAVAL QUADRIVALENT TF PFS 10s 19515-894-52 19515-894-41 42N4L 30-Apr-15
FLULAVAL QUADRIVALENT TF PFS 10s 19515-894-52 19515-894-41 5AZ7H 30-Apr-15
FLULAVAL QUADRIVALENT TF PFS 10s 19515-894-52 19515-894-41 ZS95Z 30-Apr-15
FLULAVAL QUADRIVALENT TF PFS 10s 19515-894-52 19515-894-41 A2PK7 30-Apr-15
FLULAVAL QUADRIVALENT TF PFS 10s 19515-894-52 19515-894-41 T3J4S 30-Apr-15
FLULAVAL QUADRIVALENT TF PFS 10s 19515-894-52 19515-894-41 XP4J2 30-Apr-15
FLULAVAL QUADRIVALENT TF PFS 10s 19515-894-52 19515-894-41 379MY 31-May-15
FLULAVAL QUADRIVALENT TF PFS 10s 19515-894-52 19515-894-41 AR57J 31-May-15
FLULAVAL QUADRIVALENT TF PFS 10s 19515-894-52 19515-894-41 2B472 30-Jun-15
FLULAVAL QUADRIVALENT TF PFS 10s 19515-894-52 19515-894-41 9A3ZM 30-Jun-15
FLULAVAL QUADRIVALENT TF PFS 10s 19515-894-52 19515-894-41 DR4GF 30-Jun-15
FLULAVAL QUADRIVALENT TF PFS 10s 19515-894-52 19515-894-41 YF5DT 30-Jun-15
FLULAVAL QUADRIVALENT TF PFS 10s 19515-894-52 19515-894-41 F45C5 30-Jun-15

MANUFACTURER:
GlaxoSmithKine
Saint-Foy, Canada

REASON:
GSK is voluntarily recalling all remaining lots of 2014-2015 FLULAVAL QUADRIVALENT Thimerosal-Free Pre-Filled Syringes (PFS). (This recall does not affect FLULAVAL QUADRIVALENT Multi Dose Vials (MDV), FLULAVAL [trivalent] MDV or any other GSK vaccines. As part of stability testing, GSK observed loss of potency below the minimum specification prior to product expiry for the B strains included in the vaccine.  The lots are being recalled due to the potential for reduced efficacy offered by the vaccine and not as a result of any identified safety concern.


The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.

Page Last Updated: 04/21/2015
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