FDA recall D-0469-2024

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

Product

Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-011-13

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-0469-2024