Vials of the hepatitis B vaccine RECOMBIVAX HB are being recalled by the manufacturer because a limited number of the vials in the lot may crack, the Food and Drug Administration (FDA) announced. If a crack occurs, the integrity of the vial and the sterility of any product remaining in the vial could not be assured.
Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., issued the recall for Lot Number J001183 of RECOMBIVAX HB (Recombinant) Adult Formulation. The product was distributed only in the United States between March 12, 2013, and May 2, 2013. The company says there is adequate supply to replace the recalled product at this time.
Hepatitis B is a liver disease that is caused by infection with the Hepatitis B virus. It can range in severity from a mild illness lasting a few weeks to a serious, lifelong illness. Hepatitis B is usually spread when blood, semen or another body fluid from a person infected with the virus enters the body of someone who is not infected. The best way to prevent Hepatitis B is by getting vaccinated.
Customers who have received the affected vials have been contacted and advised to inventory and quarantine the product until they receive further instructions from Merck.
Anyone who has received the vaccination and experienced any adverse effects should contact their doctor. Any side effects with this and any other medication should be reported to the FDA MedWatch Reporting Program at www.FDA.gov/MedWatch/Report.htm.