Tokushima, N/A, Japan
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. recalls
1 recall recorded since 2018, most recently on 9 April 2024. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)1
Terminated or completed0
Class I (FDA)0
Ongoing Class III Drugs
- Recall started
- 9 April 2024
- Reason
- Cross Contamination with Other Products
- Distribution
- USA nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0468-2024, D-0466-2024, D-0467-2024, D-0469-2024
- Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13
- Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13
- 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.
- Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.