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April 12, 2001

Aventis Pharmaceuticals, Inc. Recalls Taxotere for Injection Concentrate

Kansas City, MO (SafetyAlerts) - The Food and Drug Administration (FDA) said today that Aventis Pharmaceuticals, Inc. has recalled certain Taxotere (docetaxel) for Injection Concentrate because both the active ingredient vial and the diluent vial are labeled as diluents.

This is the first public notice of this Class II recall issued by FDA.

Taxotere (docetaxel) for Injection Concentrate 20-mg., 20-mg. docetaxel in 0.5 ml polysorbate 80, 10 mg/ml after the initial dilution, RX, for IV infusion only, indicated for the treatment of breast cancer and non-small cell lung cancer, NDC #0075-8001-20, NDA #20-449.

The product consists of two vials. One vial contains the Taxotere and has a green flip-top cap, and the other vial contains Diluent for Taxotere 20 mg., containing 13% (w/w) ethanol in water for injection, and has a clear flip-top cap. The two vials are packaged together in a labeled tray. The tray is contained within a labeled box.

Recall #D-165-1.

Lot #OP273 (Taxotere), OT446 (Diluent), Exp. 4/2002;
Lot #OP273 (Taxotere), OT449 (Diluent), Exp. 4/2002.

Aventis Pharma, Ltd., England, UK.

Aventis Pharmaceuticals, Inc., Kansas City, MO, via telephone on 3/23/01 and by fax on 3/27/01. Firm-initiated recall ongoing.

AL, CA, FL, IL, KY, MA, MI, MN, NC, NJ, OH, OR, SC, and TN.

28,774/2-vial units

Questions concerning this recall may be directed to the FDA at 1-888-INFO-FDA.

Notice of this product warning was sent via email to SafetyAlerts subscribers April 12, 2001.  For more information regarding the SafetyAlerts free email alert service please click here.

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

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The information contained herein has been obtained from sources that the Company believes to be reliable, however, the Company has not independently verified or confirmed the information and the recipient acknowledges that no representations or warranties are being made in connection with the use of the information.