Recombivax HB (Hepatitis B Vaccine (Recombinant)) Adult Formulation by Merck Sharp and Dohme Corp.: Recall - Potential for Cracked Vials

Source: FDA MedWatch


A subsidiary of Merck & Co. has initiated a voluntary recall of one lot of the recombinant hepatitis B vaccine Recombivax HB due to a number of possibly cracked vials in the lot. Merck noted that if the vial is cracked, the integrity of the vial and the sterility of any remaining vaccine could be compromised. The recall only affects lot number J001183 of Recombivax HB Adult Formulation; the lot was distributed between March 12, 2013 and May 2, 2013. Merck said that revaccination is not necessary if vaccine from the affected lot was administered.

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