D-012-2013 Class I Terminated
FDA drug recall D-012-2013 was initiated by Bristol-Myers Squibb Company on Aug 29, 2012 and is designated Class I. 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… The recall status is terminated (terminated Aug 12, 2013). Affected quantity: 31,481 kits.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 31, 2012
- Initiation Date
- Aug 29, 2012
- Termination Date
- Aug 12, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 31,481 kits
Product Description
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 Pattern
Nationwide and Puerto Rico.
Code Information
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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-012-2013
- openFDA file date
- Nov 3, 2026
- Loaded by RegDataLab
- Nov 4, 2026