April 12, 2001Aventis Pharmaceuticals, Inc.
Recalls Taxotere for Injection Concentrate
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
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.
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.
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.