Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Ca...

FDA Drug Recall #D-0568-2023 — Class II — April 26, 2023

Recall Summary

Recall Number D-0568-2023
Classification Class II — Moderate risk
Date Initiated April 26, 2023
Status Completed
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Apotex Corp.
Location Weston, FL
Product Type Drugs
Quantity 82,375 bottles

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.

Distribution Pattern

Nationwide throughout the United States

Lot / Code Information

Lot #: TH5645, Exp. 01/2025

Other Recalls from Apotex Corp.

Recall # Classification Product Date
D-0510-2026 Class II Desmopressin Nasal Spray, USP, 10 mcg/0.1 mL, 5... Apr 8, 2026
D-0407-2026 Class II Brimonidine Tartrate/Timolol Maleate Ophthalmic... Mar 5, 2026
D-0676-2025 Class II Brimonidine Tartrate/Timolol Maleate Ophthalmic... Sep 5, 2025
D-0677-2025 Class II Ketorolac Tromethamine Ophthalmic Solution, 0.5... Sep 5, 2025
D-0457-2025 Class II Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL... May 28, 2025

Frequently Asked Questions

Stop taking the medication and contact your pharmacist or doctor immediately. For Class I recalls, this is urgent. For Class II or III recalls, consult your doctor before stopping — abruptly discontinuing certain medications (blood pressure drugs, antidepressants, diabetes medications) can be more harmful than continuing while arranging a replacement. Check whether the recall applies to your specific lot number and expiration date. Return the product to your pharmacy and report any adverse effects to FDA MedWatch at 1-800-FDA-1088.

Not necessarily. Many drug recalls are initiated because of quality system failures or test results that suggest a product might not meet specifications — even if no patients have reported harm. The FDA uses a precautionary approach: if there is reason to believe quality standards were not met, a recall is required regardless of whether adverse effects have been reported. Class I recalls typically involve a reasonable probability of harm; Class II recalls may cause temporary health issues; Class III recalls are for products unlikely to cause adverse health consequences but that still violate regulations.

Pharmacies typically receive recall notices directly from drug wholesalers and manufacturers within days of the recall being announced. Your pharmacist can look up whether any product in your prescription history matches a recalled lot number. For current recalls, the FDA publishes updates at FDA.gov/safety/recalls-market-withdrawals-safety-alerts and sends MedWatch email alerts for significant drug safety issues. You can sign up for MedWatch alerts at FDA.gov. Most major pharmacy chains also have their own recall notification systems that automatically alert pharmacists when a recalled product is in their inventory.

What Should You Do?

Stop using this medication if affected by this recall. Contact your pharmacist or prescribing doctor immediately for guidance. Do not flush medications — use a drug take-back program.