Potential Cracks in Vials of Hepatitis B Vaccine

July 3, 2013

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (Merck), initiated a voluntary recall of RECOMBIVAX HB, a Hepatitis B vaccine (recombinant) due to the potential for a limited number of cracked vials to be present in the lot. Merck’s investigation concluded that for certain vials in the affected lot, the potential exists for a crack to have occurred in the vial. If the vial was cracked, the integrity of the vial and the sterility of any product remaining in the vial could not be assured.

Lot Number J001183 of RECOMBIVAX HB Adult Formulation is the only lot impacted by the recall and was distributed solely within the United States. The lot was distributed by Merck between March 12, 2013 and May 2, 2013. There is adequate inventory to replace recalled product at this time.

If product from this lot has been administered, revaccination is not necessary. Customers are asked to inventory and quarantine all product from Lot J001183 and follow Merck’s instructions for return of product.

Report problems with vaccine products to the Vaccine Adverse Event Reporting System (VAERS), the national vaccine safety surveillance program co-sponsored by the Centers for Disease Control and Prevention and the FDA.

Read the MedWatch Safety Alert, which includes a link to the Recall Notice.


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