Merck recalls lot of hepatitis B vaccine

July 3, 2013

Merck Sharp & Dohme Corp. on July 3, 2013 initiated a voluntary recall of 1 lot of its hepatitis B vaccine Recombinant HB Adult Formulation due to potential cracks in the vials.

Merck Sharp & Dohme Corp. on July 3, 2013 initiated a voluntary recall of 1 lot of its hepatitis B vaccine Recombinant HB Adult Formulation due to potential cracks in the vials.

A Merck’s investigation concluded that the potential exists for a crack to have occurred in the vials of lot J001183. The lot was distributed between March 12, 2013 and May 2, 2013. If a vial is cracked, the integrity of the vial and the sterility of any product remaining in the vial cannot be assured.

Merck officials advise that if a product from this lot has already been administered, revaccination is not necessary. Adverse reactions should be reported to FDA’s Vaccine Adverse Event Reporting System.

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