Drug product
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
D-0568-2023
Product summary
- Firm
- Apotex Corp.
- Event
- Event 92208
- Status
- Completed
- Classification
- Class II
- Quantity
- 82,375 bottles
- Official record key
drug-enforcement:D-0568-2023
Official wording
Reason: Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
Code information: Lot #: TH5645, Exp. 01/2025
Distribution pattern: Nationwide throughout the United States
Derived failure modes
-
Foreign material or chemical contamination
Foreign Substance