Voluntary Recall of Hepatitis B Vaccine (Recombinant),
Engerix-B
DATE RECALL INITIATED:
February 22, 2001
LOT NUMBER / EXPIRATION DATE:
ENG33824A * (partial lot) 10/27/2003
* only product distributed by Bindley Western Drug Company, Westbrook, ME is subject to recall
RECALLING FIRM (DISTRIBUTOR):
Bindley Western Drug Company
5 Bradley Drive
Westbrook, ME 04092
MANUFACTURER:
Glaxo SmithKline Beecham
Rixensart, Belgium
REASON:
There is a possibility that during shipment from Bindley Western Drug Company to their customers, the product was not maintained at the required temperature.
The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.
Last Updated: 4/5/2002
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