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March 27, 2001
URGENT: VOLUNTARY DRUG RECALL
TAXOTERE® (docetaxel) for Injection Concentrate 20-mg NDC# 0075-8001-20
Dear Wholesaler:
Aventis Pharmaceuticals is initiating a voluntary recall of Taxotereâ (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) and 0T449 (diluent).
It has been determined that the Taxotere 20mg vial containing the active ingredient may have been inadvertently labeled as a "diluent" vial. Aventis has received one product complaint relating to this mislabeling. We believe this to be an isolated event, but are nevertheless recalling all affected lots.
Please proceed with the following:
We are notifying all hospital pharmacies and oncology health care professionals of this recall. However, we ask that you also communicate this information to customers to whom you have sold the listed lots of Taxotere. If you have any questions regarding this recall, please contact our Customer Service Department at 1-800-207-8049. We appreciate your assistance and apologize for the inconvenience . We assure you that Taxotere 20-mg is available to reorder immediately.
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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