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 cannot be assured. If product from this lot has been administered, revaccination is not necessary. Lot J001183 of RECOMBIVAX HB Adult Formulation is the only lot impacted by the recall and was distributed solely within the United States.
 FDA, "Recall of RECOMBIVAX HB [Hepatitis B Vaccine (Recombinant)] (June 26, 2013).