Why it was recalled
Cross Contamination with Other Products
Product description
Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs (NDC 59148-008-95), RX only, Otsuka America Pharmaceutical, Inc.
Lot numbers, UPCs & expiration codes
Lot #: a) ALS00422A, Exp 04/30/2025; ALS00523A, Exp 11/30/2025; b) 1K77YUD1H1A, Exp 11/30/2024
Where it was sold
USA nationwide.
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-0467-2024
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Apr 9, 2024
- FDA report date
- May 1, 2024
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Original FDA data
Every field from FDA enforcement report D-0467-2024, exactly as published.
Show all FDA fields
- City
- Tokushima
- Status
- Ongoing
- Country
- Japan
- Event ID
- 94382
- Address
- 224-18
- Address (line 2)
- Kawauchi-Cho
- Code information
- Lot #: a) ALS00422A, Exp 04/30/2025; ALS00523A, Exp 11/30/2025; b) 1K77YUD1H1A, Exp 11/30/2024
- Report date
- May 1, 2024
- Product type
- Drugs
- Recall number
- D-0467-2024
- Classification
- Class III
- Recalling firm
- Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
- Reason for recall
- Cross Contamination with Other Products
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 count blister packs (NDC 59148-008-95), RX only, Otsuka America Pharmaceutical, Inc.
- Distribution pattern
- USA nationwide.
- Recall initiation date
- Apr 9, 2024
- Initial firm notification
- Letter
- Center classification date
- Apr 23, 2024