Status
Ongoing
Drug Enforcement D-0467-2024
Cross Contamination with Other Products
Classification
Class III
Report Date
May 1, 2024
Termination Date
—
Product Information
- 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.
- Product quantity
- N/A
- Reason for recall
- Cross Contamination with Other Products
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- USA nationwide.
Location & Firm
- Recalling firm
- Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
- Address
-
224-18, Kawauchi-Cho
Japan - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0467-2024
- Event ID
- 94382
- Recall initiation date
- April 9, 2024
- Center classification date
- April 23, 2024
- Code info
- Lot #: a) ALS00422A, Exp 04/30/2025; ALS00523A, Exp 11/30/2025; b) 1K77YUD1H1A, Exp 11/30/2024
- More code info
- —