Reported Mar 13, 2013 · Terminated

ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical Inc.,…

Bristol Myers Squibb Manufacturing Company

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Bristol Myers Squibb Manufacturing Company · Rd #3 Km 77.5 · Humacao, PR · 00792

Is this the product you have?

  • ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical Inc., Bristol-Myers Squibb NDC 59148-011-35
Lot codes and dates
    • 2E69023A
    • Exp. FEB 28 2015
Amount recalled
21 blister packs

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated May 2, 2013 · Data as of Sep 19, 5:51 PM UTC

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