# FDA recall D-012-2013

> **Bristol-myers Squibb Company** · Class I · drug recall initiated 2012-08-29.

## 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

- **Recall number:** D-012-2013
- **Recalling firm:** Bristol-myers Squibb Company
- **Classification:** Class I
- **Product type:** drug
- **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

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

## Citation

> AI Analytics. FDA recall D-012-2013. Retrieved 2026-05-25 from https://api.ai-analytics.org/recall/D-012-2013. Source: US FDA. Licensed CC0.

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