Voluntary Recall of Prevnar Pneumococcal 7-valent Conjugate Vaccine
March 30, 2010
Wyeth, now a part of Pfizer Inc., is voluntarily recalling the following four lots of Prevnar, Pneumococcal 7-valent Conjugate Vaccine, 0.5 mL single dose pre-filled syringes (10 per package).
E25197 (expiration date: 10/31/13)
OE28211 (expiration date: 10/31/13)
E37556 (expiration date: 10/31/13)
E38749 (expiration date: 11/30/13)
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 concluded that the affected syringes present no health or safety risk to patients. Further, there would be no expected loss of potency and 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.
FDA Web site
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