Apotex Corp.: Drug Recall

Recall #D-0881-2022 · 05/03/2022

Class III: Low Risk

Recall Details

Recall Number: D-0881-2022
Classification: Class III
Product Type: Drug
Recalling Firm: Apotex Corp.
Status: Terminated
Date Initiated: 05/03/2022
Location: Weston, FL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2353 bottles

Reason for Recall

Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.

Product Description

Sirolimus Oral Solution, 1 mg/mL, 60 mL bottle, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-6197-2

Distribution Pattern

Nationwide in the USA

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.