Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 5
Summary
The FDA issued a Class III for Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Ot by Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.. Reason: Cross Contamination with Other Products.
Details
Source
Drug Recall
External ID
D-0468-2024
Action Date
2024-05-01
Status
Ongoing
Category
drug
Product Description
Abilify (aripiprazole), 15 mg tablets, packaged in 30 count bottles, RX only, Otsuka America Pharmaceutical, Inc., NDC 59148-009-13
Lot/Code Info: Lot # AMS00223A, Exp 07/31/2025
Quantity Affected: N/A
Reason for Recall
Cross Contamination with Other Products
Distribution
USA nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2024-04-09
Company
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 96 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. have FDA actions?
Second Tokushima Factory, Otsuka Pharmaceutical Co., Ltd. has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0468-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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