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.
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