July 04--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.
"A manufacturing issue related to the glass vial was identified during
packaging," Merck spokeswoman Lainie Keller wrote in an e-mail. "The issue has
been resolved and preventative measures are in place, and this voluntary recall
is being conducted with the concurrence of the FDA. This recall does not affect
Merck's ability to supply the market. There is adequate inventory to replace
recalled product at this time."
The lot, numbered J001183, consisted of 27,020 vials of the adult formulation
and was distributed nationwide by Merck between March 12 and May 2, 2013. Merck
also makes a version for children.
Keller said she could not say which wholesalers or pharmacies or doctors got the
Hepatitis, which involves inflammation of the liver, has several forms.
The Centers for Disease Control and Prevention website says an estimated 800,000
to 1,400,000 people in the United States have chronic hepatitis B virus
infection, though many do not know it. Worldwide, chronic hepatitis B affects
about 350 million people and contributes to an estimated 620,000 deaths
worldwide each year.
The CDC says hepatitis B in the United States has decreased 82 percent since
1990, when routine vaccinations of children began.
Contact David Sell at 215-854-4506, firstname.lastname@example.org, or @phillypharma. Read
his blog at www.inquirer.com/phillypharma.
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