FDA Recall D-012-2013

Bristol-myers Squibb Company · New Brunswick, NJ

Class I — life-threatening Terminated 348 days on record

Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.

Product

BiCNU (Carmustine for injection) 100 mg and Diluent Rx Only BiCNU manufactured by: Ben Venue Laboratories, Inc. Bedford, OH 44146 Diluent manufactured by: Luitpold Pharmaceuticals, Inc. Shirley, NY 11967 Distributed by: Bristol-Meyers Squibb Company Princeton, NJ 08543 USA Made in USA NDC 0015-3012-18 NDC 0015-3012-60

Lot / code: Kit/Vial Lot #: (9L7003A/1803607), Exp 11/12; (9H4209A/1803608), Exp 01/13; (9H4211A/1843251), Exp 02/13; (0B7004A/1843251), Exp 04/13; (0B7005A/2011804), (0E7004A/2011804), Exp 05/13; (0E7006A/2055384), Exp 09/13; (0J7007A/2064024), (1A7005A/2064024), Exp 01/14; (1C7006A/2106210), Exp 04/14

Quantity: 31,481 kits

Reason for recall

Superpotent (Single Ingredient) Drug: All BiCNU lots within expiration which contain carmustine vial lots manufactured by BenVenue Laboratories (BVL) are being recalled because of an overfilled vial discovered during stability testing for a single carmustine lot.

Recall record

Recall number: D-012-2013
Classification: Class I
Status: Terminated
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide and Puerto Rico.
Recall initiated: 2012-08-29
Classified by FDA Center: 2012-10-24
FDA published: 2012-10-31
Terminated: 2013-08-12
Recalling firm: Bristol-myers Squibb Company
Firm location: New Brunswick, NJ

‹ All recalls