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February 20, 2001

Bindley Western Drug Company Recalls 1 Lot of Hepatitis B Vaccine

Westbrook, ME (SafetyAlerts)  - The Food and Drug Administration (FDA) said today that Bindley Western Drug Company is recalling one lot of Hepatitis B Vaccine (Recombinant), Engerix-B because there is a possibility that, during shipment, the product was not maintained at the required temperature.

The recalled lot of Hepatitis B Vaccine (Recombinant), Engerix-B was manufactured by Glaxo SmithKline Beecham of Rixensart, Belgium and carries the Lot Number and Expiration Date of ENG33824A 10/27/2003.   No distribution was listed in the FDA report.

The recall was initiated by the company on February 22, 2001.  This is the first noticed issued by the FDA.

Questions concerning this notice should be directed to the FDA's Center for Biologics Evaluation and Research (CBER) at 800-835-4709.

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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