D-0568-2023 Class II
Recall Details
- Product Type
- Drugs
- Report Date
- May 17, 2023
- Initiation Date
- April 26, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 82,375 bottles
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
Reason for Recall
Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
Distribution Pattern
Nationwide throughout the United States
Code Information
Lot #: TH5645, Exp. 01/2025