Calcitonin Salmon — Class II drug recall D-0568-2023
Completed recall by Apotex Corp., reported 2023-05-17, distributed nationwide. Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump i
| Recall number | D-0568-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Corp., Weston, FL, United States |
| Recall initiated | 2023-04-26 |
| Classified | 2023-05-09 |
| Reported by FDA | 2023-05-17 |
| Distributed | Nationwide (US) |
| Quantity | 82,375 bottles |
| Reason classes | foreign material |
| NDC | 60505-0823, 60505-0823-00, 60505-0823-06 |
| Lot numbers | TH5645 |
| Expiration dates | 2025-01 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0568-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.