August 2012 FDA Recall Drug by Bristol-myers Squibb Company (D-012-2013 - Superpotent (Single Ingredient) Drug)

This Class I drug recall was voluntarily initiated by Bristol-myers Squibb Company on August 29, 2012 for the product Drug. The FDA reported the reason for recall as superpotent (single ingredient) drug. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-012-2013

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.
Initiated
08-29-2012
Reported
10-31-2012
Quantity
31,481 kits

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
63043
Classification About Classification
Relative degree of health hazard assigned by FDA.
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.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Bristol-myers Squibb Company
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide and Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
08-12-2013
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 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