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. The company believes this to be an isolated event, but Aventis is nevertheless recalling the affected lots.
Health care professionals should proceed with the following:
- Examine your inventory immediately to determine if you have cartons of Taxotere
20-mg vials with the lot numbers listed above.
- Place any affected inventory on hold. You will receive a business reply card, packing slip and return label in the mail from National Notification Center within 3 – 5 days.
- On receipt of the returned product, you will be issued a credit from your distributor.
- Taxotere can immediately be reordered through normal distribution channels.
Aventis asks that health providers communicate this information to anyone who may have purchased the affected lots of Taxotere. Questions regarding this recall may be directed to Aventis Customer Service at 1-800-207-8049. For Medical Information questions or to report an Adverse Event please call, 1-800-633-1610. The company appreciates any assistance and apoliges for the inconvenience. Taxotere 20-mg is available immediately for order.