FDA recall D-012-2013

Bristol-myers Squibb Company · Class I · drug

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

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.

Distribution

Nationwide and Puerto Rico.

Key facts

Status: Terminated
Initiation date: 2012-08-29
Report date: 2012-10-31
Termination date: 2013-08-12
Voluntary/Mandated: Voluntary: Firm initiated
Location: New Brunswick, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-012-2013