For July 3, 2013:


CLASSIFICATION:

Class II

PRODUCT:

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

CODE:

J001183

RECALLING FIRM/MANUFACTURER:

Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. (Merck)
West Point, PA, by letter dated June 26, 2013. Firm initiated recall is ongoing.

REASON:

Recombivax HB, one lot with the potential for a crack to have occurred in the vial, was distributed.

VOLUME OF PRODUCT IN COMMERCE:

1 Lot; (27,020 vials)

DISTRIBUTION PATTERN:

Nationwide