Recalls / Class I

Class ID-012-2013

Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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

Affected lot / code info: 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

Why it was recalled

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.

Recalling firm

Firm: Bristol-myers Squibb Company
Notification channel: Letter
Type: Voluntary: Firm initiated
Address: 1 Squibb Dr, N/A, New Brunswick, New Jersey 08901

Distribution

Quantity: 31,481 kits
Distribution pattern: Nationwide and Puerto Rico.

Timeline

Recall initiated: 2012-08-29
FDA classified: 2012-10-24
Posted by FDA: 2012-10-31
Terminated: 2013-08-12
Status: Terminated

Source: openFDA Drug Enforcement endpoint. Recall record D-012-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.