Abilify (aripiprazole), 30 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Phar...

FDA Recall #D-0469-2024 — Class III — April 9, 2024

Recall #D-0469-2024 Date: April 9, 2024 Classification: Class III Status: Ongoing

Product Description

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

Recalling Firm

Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. — Tokushima, N/A

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

N/A

Distribution

USA nationwide.

Code Information

Lot # APS00423A, Exp 07/31/2025; APS00222A, Exp 11/30/2024

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated