FDA: Potential For Cracked Vials in Recombivax HB by Merck

RECOMBIVAX HB (Hepatitis B Vaccine (Recombinant)) Adult Formulation by Merck Sharp and Dohme Corp.: Recall - Potential For Cracked Vials

AUDIENCE: Pharmacy, Patient, Health Professional

ISSUE: Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (Merck), initiated this voluntary recall 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.

BACKGROUND:  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.

RECOMMENDATION: 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.
 

Posted: July 2013


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