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

FDA recall notice · announced May 17, 2023 · Apotex

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The 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

Reason for recall

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

Notes

Distribution: Nationwide throughout the United States
Lot/code information: Lot #: TH5645, Exp. 01/2025
Quantity: 82,375 bottles
Status: Completed
Products in this recall event:
- 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, C (D-0568-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.