Apotex Corp.: Drug Recall

Recall #D-1285-2022 · 07/07/2022

Class II: Risk

Recall Details

Recall Number: D-1285-2022
Classification: Class II
Product Type: Drug
Recalling Firm: Apotex Corp.
Status: Terminated
Date Initiated: 07/07/2022
Location: Weston, FL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2010 bottles

Reason for Recall

Failed dissolution specifications: OOS for dissolution at the 12-month stability time point.

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

Distribution Pattern

USA Nationwide

Other Recalls by Apotex Corp.

Class II: Risk 09/05/2025

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Class II: Risk 09/05/2025

Lack of Assurance of Sterility; atypical weight loss due to improper bottle sealing leading to potential sterility concerns
Class II: Risk 05/28/2025

Lack of Assurance of Sterility
Class II: Risk 05/28/2025

Lack of Assurance of Sterility
Class II: Risk 05/28/2025

Defective Container: This recall is being initiated due to a leaking unit stored horizontally.

View all recalls by Apotex Corp. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.