Vaccines, Blood & Biologics

Recall: Prevnar Pneumococcal 7-valent Conjugate Vaccine, Wyeth

DATE RECALL INITIATED:

March 22, 2010

PRODUCT / LOT NUMBER / EXPIRATION DATE:

Prevnar Pneumococcal 7-valent Conjugate Vaccine
(Diphtheria CRM197Protein)
0.5 mL single dose pre-filled syringe (10 per package)

Prevnar Pneumococcal 7-valent Conjugate Vaccine
Lot Numbers Expiration Date
E25197 October 31, 2013
E28211 October 31, 2013
E37556 October 31, 2013
E38749 November 30, 2013

MANUFACTURER:

Wyeth
Pearl River, New York

REASON:

Wyeth, now a part of Pfizer Inc., is voluntarily recalling the above four lots of Prevnar, Pneumococcal 7-valent Conjugate Vaccine, single dose pre-filled syringes. During a routine physical inspection of Prevnar pre-filled syringes, Wyeth determined that a potential exists for syringes to have been distributed with a rubber formulation in the syringe tip caps that was not approved for use with Prevnar. Wyeth performed a medical assessment and has concluded that the affected syringes present no health or safety risk to patients. Further, there would be no expected loss of potency and there is no need to revaccinate children who may have received a dose of Prevnar from an affected syringe. Customers are asked to contact the manufacturer to arrange for product return.


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: 08/21/2014
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