BETHESDA, MD 02 Jul 2013—Merck Sharp & Dohme Corp. on June 26 started recalling all vials of Recombivax HB in lot J001183 because some may be cracked, according to a notice posted online today by FDA.
The company, in a separate announcement (PDF), said it distributed the vials between March 12 and May 2, 2013, and has contacted all direct customers who purchased vials in the lot.
Customers who purchased the vials from a distributor or wholesaler will receive instructions from that entity, Merck said.
People who received a vaccine dose from lot J001183 do not need to repeat the dose, the company said. Vials in the lot contain the adult formulation of the recombinant hepatitis B vaccine, or 10 µg of hepatitis B surface antigen per 1 mL.
The company, a subsidiary of Merck & Co. Inc., said it has enough inventory to replace the vials being recalled.