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Wyeth has voluntarily recalled one lot of single-dose prefilled syringes of Prevnar, the company?s pneumococcal 7-valent conjugate vaccine.
Wyeth has voluntarily recalled one lot of single-dose prefilled syringes of Prevnar, the company’s pneumococcal 7-valent conjugate vaccine. During a routine physical reconciliation of Prevnar prefilled syringes, Wyeth determined that a portion of a bulk lot of prefilled syringes, which was not intended for commercial use, was inadvertently packaged and distributed with commercial product, in lot D50002.
Although some of the units of the recalled lot were not intended for the commercial market, Wyeth performed a quality assessment and has concluded that the affected syringes present no health or safety risk to patients and that there is no need to revaccinate.
“These doses were intended to be held back for internal testing purposes,” explained Doug Petkus, a Wyeth spokesperson. “They contained the same product as the commercial doses, but were not packaged for commercial distribution.”
The recalled lot was distributed in the United States during January and February from the company’s site in Pearl River, NY, where the vaccine is packaged. The lot contained 0.5-mL single dose prefilled syringes, with national drug code (NDC) number 0005-1970-50, with an expiration date of February 28, 2011. The recall began on July 10.