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Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
FDA Regulatory Profile
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 0
- Inspections
- 7
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
| D-0466-2024 | Class III | Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmace | April 9, 2024 |
| D-0468-2024 | Class III | Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmac | April 9, 2024 |
| D-0467-2024 | Class III | Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 c | April 9, 2024 |
| D-0469-2024 | Class III | Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmac | April 9, 2024 |