Recalls / Class II
Class IID-181-2013
Product
ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical Inc., Bristol-Myers Squibb NDC 59148-011-35
- Brand name
- Abilify
- Generic name
- Aripiprazole
- Active ingredient
- Aripiprazole
- Route
- Oral
- NDCs
- 59148-006, 59148-007, 59148-008, 59148-009, 59148-010, 59148-011
- FDA application
- NDA021436
- Affected lot / code info
- 2E69023A, Exp. FEB 28 2015
Why it was recalled
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.
Recalling firm
- Firm
- Bristol Myers Squibb Manufacturing Company
- Manufacturer
- Otsuka America Pharmaceutical, Inc.
- Notification channel
- Telephone
- Type
- Voluntary: Firm initiated
- Address
- Rd #3 Km 77.5, N/A, Humacao, Puerto Rico 00792
Distribution
- Quantity
- 21 blister packs
- Distribution pattern
- LA, TN, CA
Timeline
- Recall initiated
- 2012-11-02
- FDA classified
- 2013-03-04
- Posted by FDA
- 2013-03-13
- Terminated
- 2013-05-02
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-181-2013. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.