Drug Enforcement D-0468-2024

Cross Contamination with Other Products

Status

Ongoing

Classification

Class III

Report Date

May 1, 2024

Termination Date

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Product Information

Product description
Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13
Product quantity
N/A
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-0468-2024
Event ID
94382
Recall initiation date
April 9, 2024
Center classification date
April 23, 2024
Code info
Lot # AMS00223A, Exp 07/31/2025
More code info
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