Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count
Summary
The FDA issued a Class II for Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2 by Apotex Corp.. Reason: Failed dissolution specifications: OOS for dissolution at the 12-month stability time point..
Details
Source
Drug Recall
External ID
D-1285-2022
Action Date
2022-07-27
Status
Terminated
Category
drug
Product Description
Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 60505-2676-8, UPC 3 60505 26768 2), b) 30-count bottle (NDC 60505-2676-3, UPC 3 60505 26763 7), Rx only, Manufactured by: Apotex, Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326
Lot/Code Info: Lots: a) TD9591 Exp. 04/2023; b) TD9592 Exp. 04/2023
Quantity Affected: 2010 bottles
Reason for Recall
Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2022-07-07
Company
Weston, FL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 115 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Apotex Corp. has 19 FDA actions in our database, including 18 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
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 (Apotex Corp.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Apotex Corp. have FDA actions?
Apotex Corp. has 19 FDA actions in our database, including 18 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1285-2022" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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