FDA recall D-0467-2024

Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. · Class III · drug

Product

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.

Reason for recall

Cross Contamination with Other Products

Distribution

USA nationwide.

Key facts

Status: Ongoing
Initiation date: 2024-04-09
Report date: 2024-05-01
Voluntary/Mandated: Voluntary: Firm initiated
Location: Tokushima, N/A, Japan

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0467-2024