Apotex Corp.: Drug Recall

Recall #D-0119-2024 · 11/01/2023

Class II: Risk

Recall Details

Recall Number: D-0119-2024
Classification: Class II
Product Type: Drug
Recalling Firm: Apotex Corp.
Status: Ongoing
Date Initiated: 11/01/2023
Location: Weston, FL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 34,392

Reason for Recall

Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient Amadori Glucose adduct of Paroxetine

Product Description

Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, NDC#: 60505-0097-1; b) 100-count bottle, NDC#: 60505-0097-2; c) 1000-count bottle, NDC#: 60505-0097-4, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326.

Distribution Pattern

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.