If there is a crack in the vial, the integrity of the vial and sterility of any remaining product can be compromised. Recombivax HB Adult Formulation is indicated for hepatitis B immunization.
The only affected products have the lot #J001183 that were distributed between March 12, 2013–May 2, 2013. Currently, there is adequate inventory to replace the recalled product.
Revaccination is not necessary if the product from this lot has been administered. It is recommended to inventory and quarantine all products from Lot #J001183 and follow Merck’s instructions for return of a product.
For more information visit FDA.gov.