FDA-Drug2013-03-13Class II

ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical Inc., Bristol-Myers Squibb NDC 59148-011-35

Bristol Myers Squibb Manufacturing Company
Hazard

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.

Sold states
LA, TN, CA
Affected count
21 blister packs
Manufactured in
Rd #3 Km 77.5, N/A, Humacao, PR, United States
Products
ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical Inc., Bristol-Myers Squibb NDC 59148-011-35

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-181-2013

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