FDA Drug recall D-012-2013
BiCNU (Carmustine for injection) 100 mg and Diluent Rx Only BiCNU manufactured by: Ben Venue Laboratories, Inc
- FDA Drug
- Class I
- terminated
- Published 2012-10-31
On 2012-10-31 the FDA classified a Class I recall of BiCNU (Carmustine for injection) 100 mg and Diluent Rx Only BiCNU manufactured by: Ben Venue Laboratories, Inc by Bristol Myers Squibb, citing superpotent (Single Ingredient) Drug: All BiCNU lots within expiration which contain carmustine vial lots manufactured by BenVenue Laboratories (BVL) are being recalled because of….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-012-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2012-08-29 |
| Published | 2012-10-31 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Bristol Myers Squibb |
| Distribution | US |
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
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.
Identifiers
| code_info | Kit/Vial Lot #: (9L7003A/1803607), Exp 11/12; (9H4209A/1803608), Exp 01/13; (9H4211A/1843251), Exp 02/13; (0B7004A/1843…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-012-2013%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.