Recalls / Class II
Class IID-0568-2023
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
- Brand name
- Calcitonin Salmon
- Generic name
- Calcitonin Salmon
- Active ingredient
- Calcitonin Salmon
- Route
- Nasal
- NDC
- 60505-0823
- FDA application
- ANDA076396
- Affected lot / code info
- Lot #: TH5645, Exp. 01/2025
Why it was recalled
Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
Recalling firm
- Firm
- Apotex Corp.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2400 N Commerce Pkwy Ste 400, N/A, Weston, Florida 33326-3253
Distribution
- Quantity
- 82,375 bottles
- Distribution pattern
- Nationwide throughout the United States
Timeline
- Recall initiated
- 2023-04-26
- FDA classified
- 2023-05-09
- Posted by FDA
- 2023-05-17
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0568-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.