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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall: Prevnar Pneumococcal 7-valent Conjugate Vaccine, Wyeth

DATE RECALL INITIATED:

July 10, 2009

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Prevnar pneumococcal 7-valent Conjugate Vaccine
(Diptheria CRM197Protein)   

0.5 mL single dose pre-filled syring (10 per package)
NDC:  0005-1970-50 (10’s)/0005-1970-49 (Singles)

Lot Number:  D50002

Expiration Date:  February 28, 2011

MANUFACTURER:

Wyeth

Philadelphia, PA

REASON:

Wyeth is voluntarily recalling the above lot of Prevnar®, Pneumococcal 7-valent Conjugate Vaccine, single dose pre-filled syringes.  During a routine physical reconciliation of Prevnar® pre-filled syringes, Wyeth determined that a portion of a bulk lot of pre-filled syringes, which was not intended for commercial use, was inadvertently packaged and distributed with commercial product under Lot D50002.  The product distributed as Lot D50002 met Wyeth’s quality acceptance criteria.  Although some of the units of Lot D50002 were not intended for the commercial market, Wyeth performed a medical assessment and has concluded that the affected syringes present no health or safety risk to patients and that there is no need to revaccinate.


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.