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SafetyAlerts
April 17, 2002

Ben Venue Laboratories Has Recalled Paclitaxel Injection

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 Multiple-Dose vials.

PRODUCT
Paclitaxel Injection, 6 mg/ml, packaged in 5 ml, 16.7ml, and 50 ml Multiple-Dose vials, Rx only. Recall # D-233-2.

CODE
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/MANUFACTURER
Recalling Firm: Ben Venue Laboratories, Inc., Bedford, OH, by letters on March 5, 2002. Firm initiated recall is ongoing.

REASON
Impurity levels are exceeding specifications (during stability testing).

VOLUME OF PRODUCT IN COMMERCE
33,216 vials.

DISTRIBUTION
Nationwide and Puerto Rico
.

 
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.