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

NumberClassProductDate
D-0466-2024Class IIIAbilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America PharmaceApril 9, 2024
D-0468-2024Class IIIAbilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America PharmacApril 9, 2024
D-0467-2024Class IIIAbilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) 7 cApril 9, 2024
D-0469-2024Class IIIAbilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America PharmacApril 9, 2024