FDA Drug recall D-0568-2023
Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Calcitonin Salmon Units/spray, 3.7 mL bottle…
- FDA Drug
- Class II
- completed
- Published 2023-05-17
On 2023-05-17 the FDA classified a Class II recall of Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Calcitonin Salmon Units/spray, 3.7 mL bottle… by Apotex, citing presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0568-2023 |
| Classification | Class II |
| Status | completed |
| Initiated | 2023-04-26 |
| Published | 2023-05-17 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Apotex |
| Distribution | US |
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
Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
Identifiers
| ndc | 60505-0823-0 |
|---|---|
| ndc | 60505-0823-6 |
| code_info | Lot #: TH5645, Exp. 01/2025 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: completed.
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Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0568-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.