0x0E Bitsraised in a barn by hippy wolves

Fri Jul 17 21:27:00 CDT 2009

Just one lot of Prevnar. Got mixed up with...uh...something not intended to be shipped in that lot.

Reported on FDA site and talked about in WSJ.

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‰Ûªs)/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 Prevnarå¨, Pneumococcal 7-valent Conjugate Vaccine, single dose pre-filled syringes. During a routine physical reconciliation of Prevnarå¨ 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‰Ûªs 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.