Hepatitis B Vaccine Recalled Due to Cracked Vials

Merck recalled Hepatitis B Vaccine (Recombinant), Adult Formulation,10 ug/ml, due to a number of cracked vials. The lot- J001183- 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, Adult Formulation,10 ug/ml, 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.


See the Recall


See also Medical Law Perspectives, January 2013 Report: Vaccines: An Ounce of Prevention May Lead to a Pound of Injury