Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported October 31, 2012
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
Superpotent (Single Ingredient) Drug: All BiCNU lots within expiration which contain carmustine vial lots manufactured by BenVenue Laboratories (BVL) are being recalled because of…
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Bristol-myers Squibb Company recalled BiCNU (Carmustine for injection) 100 mg and Diluent Rx Only BiCNU manufactured by: Ben … - a critical-severity action.
BiCNU (Carmustine for injection) 100 mg and Diluent Rx Only BiCNU manufactured by: Ben … was recalled by Bristol-myers Squibb Company in October 31, 2012. Reason: Superpotent (Single Ingredient) Drug: All BiCNU lots within expiration which contain carmustine vial lots man…. Check the official notice for the remedy. Verify recall #D-012-2013 with the FDA Drug before acting.
The recall
Bristol-myers Squibb Company issued this critical-severity FDA Drug recall-Superpotent (Single Ingredient) Drug: All BiCNU lots within expiration which contain carmustine vial lots man….
- Critical
- severity level
- Class I
- classification
- October 31, 2012
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-012-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-012-2013) was formally reported on October 31, 2012, with the manufacturer initiating the action on August 29, 2012. It is classified under Critical severity (Class I), with a current status of Terminated. Bristol-myers Squibb Company is listed as the recalling firm, operating out of New Brunswick, NJ. Federal records list the affected scope as 31,481 kits.
The documented reason for this recall is: 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 st… Distribution data in the federal record shows the product reached: Nationwide and Puerto Rico.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
31,481 kits
Related Recalls
6
5 from same agency
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-012-2013 |
| Date reported | October 31, 2012 |
| Date initiated | August 29, 2012 |
| Recalling firm | Bristol-myers Squibb Company |
| Firm location | New Brunswick, NJ |
| Affected scope | 31,481 kits |
| Distribution | Nationwide and Puerto Rico. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-012-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product 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. Recalled by Bristol-myers Squibb Company. Units affected: 31,481 kits.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 31, 2012. Severity: Critical. Recall number: D-012-2013.
Where was the recalled product distributed? ▼
Distribution: Nationwide and Puerto Rico..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-012-2013) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported October 31, 2012. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.