Bristol-Myers Squibb Recalls BiCNU Injection Kits Due to Overfilled Vials
Bristol-Myers Squibb is recalling 31,481 BiCNU kits nationwide and in Puerto Rico because stability testing revealed an overfilled vial in a single lot.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class I recall, which per the rubric mandates a minimum severity score of 4 (Severe).
Plain-English summary
Bristol-Myers Squibb Company is recalling 31,481 kits of BiCNU (Carmustine for injection) 100 mg and Diluent. The kits were distributed nationwide and in Puerto Rico. The BiCNU component was manufactured by Ben Venue Laboratories, Inc., and the diluent was manufactured by Luitpold Pharmaceuticals, Inc.
The recall was initiated because an overfilled vial was discovered during stability testing for a single carmustine lot. As a precaution, all BiCNU lots within their expiration dates that contain carmustine vials manufactured by Ben Venue Laboratories are being recalled. The affected lots have expiration dates ranging from November 2012 to April 2014.
Healthcare providers and pharmacies should stop using the affected BiCNU kits and contact Bristol-Myers Squibb for instructions on how to return the product. Patients who have already received the medication should contact their healthcare provider with any questions or concerns.
The recalled product
- 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…
- Manufacturer
- Bristol-myers Squibb Company
- Category
- Drug — Injectable Oncology
- Hazard
- Affected units
- 31,481
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (18)
- 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
Distribution
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