Friday, July 5, 2013

Possibility of cracked vials leads to Merck recall of hepatitis B vaccine

Possibility of cracked vials leads to Merck recall of hepatitis B vaccine

July 4, 2013 1:03 pm by Sell, David

Merck & Co., said Wednesday that it was recalling one lot of its hepatitis B vaccine Recombivax HB that was made in West Point, Montgomery County, because of fears that some of the vials could have cracked.

The U.S. Food and Drug Administration posted a notice of the voluntary recall on its website. The medication is delivered via injection.

"Merck's investigation concluded that for certain vials in the affected lot, the potential exists for a crack to have occurred in the vial," the FDA said in its statement. "If the vial was cracked, the integrity of the vial and the sterility of any product remaining in the vial could not be assured."

Merck's facilities in West Point handle some of the company's research and development of medicine, along with some manufacturing.

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