Apotex Corp.: Drug Recall

Recall #D-0568-2023 · 04/26/2023

Class II: Risk

Recall Details

Recall Number: D-0568-2023
Classification: Class II
Product Type: Drug
Recalling Firm: Apotex Corp.
Status: Completed
Date Initiated: 04/26/2023
Location: Weston, FL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 82,375 bottles

Reason for Recall

Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.

Product Description

Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Calcitonin Salmon Units/spray, 3.7 mL bottle, Rx only, Manufactured by: Apotex Corp., Toronto, Ontario, Canada, M9L 1T9, NDC 60505-0823-6

Distribution Pattern

Nationwide throughout the United States

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.