Windley Western Drug Company Recalls 1 Lot of Hepatitis B Vaccine
SafetyAlerts February 20, 2001
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
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
the FDA's Center for Biologics Evaluation and Research (CBER) at 800-835-4709.
â¢ Vaccine is heat unstable; a shift of >4Â°C (40Â°F) will change the molecular
structure of the vaccine. (from package insert for Recombivax)