November 2012 FDA Recall Abilify by Bristol Myers Squibb Manufacturing Company
D-181-2013 - CGMP Deviations
This Class II drug recall was voluntarily initiated by Bristol Myers Squibb Manufacturing Company on November 2, 2012 for the product Abilify. The FDA reported the reason for recall as cgmp deviations. The product was distributed in LA, TN, CA and the recall is currently terminated.
Recall Number: D-181-2013
CGMP Deviations: A drum of Abilify 30 mg Tablets rejected during the compression stage was not segregated from the other portion of the lot and was inadvertently shipped, packaged and distributed.
11-02-2012
03-13-2013
21 blister packs
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Bristol Myers Squibb Manufacturing Company
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Telephone
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
LA, TN, CA
05-02-2013
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical Inc., Bristol-Myers Squibb NDC 59148-011-35
Batch or Lot Expiration Information
Lot# 2E69023A, Exp. FEB 28 2015
