February 20, 2001Bindley Western Drug Company
Recalls 1 Lot of Hepatitis B Vaccine
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
comprehensive safety recall information for the United States. SafetyAlerts Newsletter is a free email service to warn
consumers of faulty products and contaminated foods. For complete information regarding
current recalls, past recalls and timely product warning notification visit: www.safetyalerts.com.