Drug Enforcement D-0466-2024

Cross Contamination with Other Products

Status

Ongoing

Classification

Class III

Report Date

May 1, 2024

Termination Date

—

Product Information

Product description
Abilify (aripiprazole), 5 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-007-13
Product quantity
108,192/30 count bottles or 7 count blister packs
Reason for recall
Cross Contamination with Other Products
Recall initiation reason
—
Initial firm notification
Letter
Distribution pattern
USA nationwide.

Location & Firm

Recalling firm
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.
Address
224-18, Kawauchi-Cho

Japan
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0466-2024
Event ID
94382
Recall initiation date
April 9, 2024
Center classification date
April 23, 2024
Code info
Lot # AKS00623A, Exp 01/31/2026; AKS00322A, Exp 02/28/2025
More code info
—