Vaccines, Blood & Biologics

Recall of RECOMBIVAX HB [Hepatitis B Vaccine (Recombinant)]

DATE RECALL INITIATED: June 26, 2013

PRODUCT / LOT NUMBER

RECOMBIVAX HB [Hepatitis B Vaccine (Recombinant)], Adult Formulation, 10 ug/mL

Lot Number J001183

MANUFACTURER:

Merck Sharp & Dohme Corporation
West Point, PA

REASON:

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (Merck), is initiating this voluntary recall due to the potential for a limited number of cracked vials to be present in the lot. The lot was distributed by Merck between March 12, 2013 and May 2, 2013.

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.

If product from this lot has been administered, revaccination is not necessary. The supply of RECOMBIVAX HB will not be impacted by this recall. Lot J001183 of RECOMBIVAX HB Adult Formulation is the only lot impacted by the recall and was distributed solely within the United States. There is adequate inventory to replace recalled product at this time.

Customers are asked to inventory and quarantine all product from Lot J001183 and follow Merck’s instructions for return of product.


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: 08/19/2014
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