April 17, 2002
Ben Venue Laboratories Has Recalled Paclitaxel
Bedford, OH (SafetyAlerts)
- The Food and Drug Administration (FDA) said that Ben Venue Laboratories, Inc. has recalled Paclitaxel Injection, 6 mg/ml, packaged in 5 ml, 16.7ml, and 50 ml
Paclitaxel Injection, 6 mg/ml, packaged in 5 ml, 16.7ml, and 50 ml
Multiple-Dose vials, Rx only. Recall # D-233-2.
Lot Numbers/Expiration Dates:
#271220, Exp. June 2003; #236135, Exp. June 2003;
#236137, Exp. July 2003; #323242, Exp. Aug 2003;
#271224, Exp. Aug 2003; #271225, Exp. Aug 2003;
#271226, Exp. Aug 2003; #271227, Exp. Sept 2003.
Recalling Firm: Ben Venue Laboratories, Inc., Bedford, OH, by letters on
March 5, 2002. Firm initiated recall is ongoing.
Impurity levels are exceeding specifications (during stability testing).
VOLUME OF PRODUCT IN COMMERCE
Nationwide and Puerto Rico.