CLASS II Drug recall · Reported 17 May 2023 · FDA Enforcement Report
Calcitonin Salmon (synthetic origin) Nasal Spray recalled by Apotex
Apotex is recalling Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, distributed nationwide in the US. The recall was initiated on 26 Apr 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0568-2023
- FDA event ID
- 92208
- Recalling firm
- Apotex, Weston, FL
- Brand
- Calcitonin Salmon
- Manufacturer
- Apotex Corp.
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 26 Apr 2023
- FDA classified
- 9 May 2023
- Reported
- 17 May 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Foreign Material
- Drug class
- Nasal Sprays
Timeline
| 26 Apr 2023 | Recall initiated by company | |
| 9 May 2023 | Classified by FDA | +13 days |
| 17 May 2023 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
Foreign material recalls cover pieces of metal, plastic, glass, wood or other objects that got into the product during processing and could cause injury if eaten.
Product as listed by the FDA
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
Where it was distributed
Nationwide throughout the United States
Questions about this recall
Why was it recalled?
Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
Which lots are affected?
Lot #: TH5645, Exp. 01/2025
Where was it sold?
Nationwide throughout the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Calcitonin Salmon recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Calcitonin Salmon Nasal Spray recalled by Endo PharmaceuticalsCalcitonin Salmon | Endo Pharmaceuticals | Potency & Assay | Nationwide |