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.
Product description
ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical Inc., Bristol-Myers Squibb NDC 59148-011-35
Lot numbers, UPCs & expiration codes
2E69023A, Exp. FEB 28 2015
Where it was sold
LA, TN, CA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-181-2013
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Nov 2, 2012
- FDA report date
- Mar 13, 2013
- Quantity
- 21 blister packs
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Bristol Myers Squibb Manufacturing Company
Original FDA data
Every field from FDA enforcement report D-181-2013, exactly as published.
Show all FDA fields
- City
- Humacao
- State
- PR
- Status
- Terminated
- Country
- United States
- Event ID
- 63706
- Address
- Rd #3 Km 77.5
- Code information
- 2E69023A, Exp. FEB 28 2015
- Postal code
- 00792
- Report date
- Mar 13, 2013
- Product type
- Drugs
- Recall number
- D-181-2013
- Classification
- Class II
- Recalling firm
- Bristol Myers Squibb Manufacturing Company
- Product quantity
- 21 blister packs
- Termination date
- May 2, 2013
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- ABILIFY (aripiprazole) Tablets, 30 mg, Rx only, Blister Pack of 100 tablets, Otsuka America Pharmaceutical Inc., Bristol-Myers Squibb NDC 59148-011-35
- Distribution pattern
- LA, TN, CA
- Recall initiation date
- Nov 2, 2012
- Initial firm notification
- Telephone
- Center classification date
- Mar 4, 2013