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March 27, 2001
URGENT: VOLUNTARY DRUG RECALL
TAXOTERE® (docetaxel) for Injection Concentrate 20-mg NDC# 0075-8001-20
Dear Health Care Professional:
Aventis Pharmaceuticals is initiating a voluntary recall of Taxotere® (docetaxel) for Injection Concentrate 20-mg active and diluent vials. The lot numbers for this recall are: 0P273 (active) which was packaged together with diluent vials with the following lot numbers 0T446 (diluent) or 0T449 (diluent).
It has been determined that the Taxotere 20mg vial containing the active ingredient may have inadvertently been labeled as a "diluent" vial. Aventis has received one product complaint related to this mislabeling. We believe this to be an isolated event, but are nevertheless recalling the affected lots.
Please proceed with the following:
We ask that you please communicate this information to anyone who may have purchased the affected lots of Taxotere from your facility. If you have any questions regarding this recall, you may contact our Customer Service Department at 1-800-207-8049. For Medical Information questions or to report an Adverse Event please call, 1-800-633-1610. We appreciate your assistance; we apologize for the inconvenience and assure you that Taxotere 20-mg is available immediately for order.
Sincerely,
John Leone
Sr. Vice President & Chief Operating Officer
US Commercial Operations
Aventis Pharmaceuticals
300 Somerset Corporate Boulevard
Bridgewater, NJ 08807-2854
www.aventispharma-us.com
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