ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical Inc., Bristol-Myers Squibb NDC 59148-011-35
FDA recall notice · announced March 13, 2013 · Bristol Myers Squibb Manufacturing
Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.
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
Reason for recall
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.
Notes
Distribution: LA, TN, CA
Lot/code information: 2E69023A, Exp. FEB 28 2015
Quantity: 21 blister packs
Status: Terminated
Products in this recall event:
- ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical Inc., Bristol-Myers Squibb NDC 59148-011-35 (D-181-2013)
Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.