Cracked Vials Result in Recombivax Hepatitis B Vaccine Recall

Following the discovery of cracked vials, at least one lot of the hepatitis B vaccine Recombivax, distributed by Merck & Co., has been removed from the market.  

The FDA announced the Recombivax vaccine recall on July 3, after cracked vials were found in the adult formulation of the drug. A cracked vial can affect the integrity of the vial and sterility of any remaining medication in the vial.

A manufacturing issue related to the glass vials was identified during packaging and the manufacturer indicates that issue has been resolved. Preventative measures were put into place to mitigate the issue. According to Merck, there is no need for revaccination if a vaccine was given using product from the affected lot.

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The recall affects 27,000 vials of lot J001183 of Recombivax HB [Hepatitis B Vaccine (Recombinant)], Adult Formulation, 10 ug/mL. The recalled vaccine vials were distributed between March 12 and May 2 of this year.

The Recombivax HB vaccine is delivered by injection to protect against the hepatitis B virus. Hepatitis B causes inflammation of the liver in various forms and affects nearly 1.4 million people in the United States. Nearly 350 million people worldwide are infected with the hepatitis B virus, causing more than 600,000 deaths each year globally.

Occurrences of hepatitis B decreased 82% in the United States in 1990, after routine hepatitis vaccinations in children began, according to the U.S. Centers for Disease Control and Prevention. Merck says there is adequate inventory to replace the affected product without any shortage to the supply.

Merck recommends customers who purchased the vaccine check their inventory and quarantine all affected product and return it to Stericycle Inc. by calling 877-245-8143. Stericycle is the medical waste management company being used by Merck to collect all affected vials of the vaccine.


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