US Drug Recall Register
Class I · High risk Terminated Initiated Aug 29, 2012 (14 years ago)

BiCNU (Carmustine for injection) 100 mg and Diluent Rx Only BiCNU manufactured by: Ben…

Class I — High risk. Reasonable probability of serious harm or death.

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.

What was recalled

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

Recalling firm
Bristol-myers Squibb Company
NDC code
0015-3012-18
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-012-2013

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.