AUDIENCE: Pharmacy, Patient, Health Professional
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.
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
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, including a link to the Recall Notice, at:
Labels: FDA Warning, recall