Severity
Moderate
ModerateClass IICompleted
FDA Drug recall · Reported May 17, 2023
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
Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Apotex Corp. recalled Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 20… - a moderate-severity action.
Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 20… was recalled by Apotex Corp. in May 17, 2023. Reason: Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump …. Check the official notice for the remedy. Verify recall #D-0568-2023 with the FDA Drug before acting.
The recall
Apotex Corp. issued this moderate-severity FDA Drug recall-Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump ….
- Moderate
- severity level
- Class II
- classification
- May 17, 2023
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0568-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0568-2023) was formally reported on May 17, 2023, with the manufacturer initiating the action on April 26, 2023. It is classified under Moderate severity (Class II), with a current status of Completed. Apotex Corp. is listed as the recalling firm, operating out of Weston, FL. Federal records list the affected scope as 82,375 bottles.
The documented reason for this recall is: Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable. Distribution data in the federal record shows the product reached: Nationwide throughout the United States. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
82,375 bottles
Related Recalls
6
0 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Completed |
| Recall number | D-0568-2023 |
| Date reported | May 17, 2023 |
| Date initiated | April 26, 2023 |
| Recalling firm | Apotex Corp. |
| Firm location | Weston, FL |
| Affected scope | 82,375 bottles |
| Distribution | Nationwide throughout the United States |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0568-2023) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Apotex Corp.. Units affected: 82,375 bottles.
Why was this product recalled? ▼
Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on May 17, 2023. Severity: Moderate. Recall number: D-0568-2023.
Where was the recalled product distributed? ▼
Distribution: Nationwide throughout the United States.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0568-2023) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported May 17, 2023. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.