Abilify (aripiprazole), 10 mg tablets, packaged in a) 30 count bottles (NDC 59148-008-13) and b) ...

FDA Recall #D-0467-2024 — Class III — April 9, 2024

Recall #D-0467-2024 Date: April 9, 2024 Classification: Class III Status: Ongoing

Product Description

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

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 #: a) ALS00422A, Exp 04/30/2025; ALS00523A, Exp 11/30/2025; b) 1K77YUD1H1A, Exp 11/30/2024

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated