Why it was recalled
Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
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
Lot numbers, UPCs & expiration codes
Lot #: TH5645, Exp. 01/2025
Where it was sold
Nationwide throughout the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0568-2023
- Classification
- Class II
- Status
- Completed
- Recall initiated
- Apr 26, 2023
- FDA report date
- May 17, 2023
- Quantity
- 82,375 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Apotex Corp.
Original FDA data
Every field from FDA enforcement report D-0568-2023, exactly as published.
Show all FDA fields
- City
- Weston
- State
- FL
- Status
- Completed
- Country
- United States
- Event ID
- 92208
- Address
- 2400 N Commerce Pkwy Ste 400
- Code information
- Lot #: TH5645, Exp. 01/2025
- Postal code
- 33326-3253
- Report date
- May 17, 2023
- Product type
- Drugs
- Recall number
- D-0568-2023
- Classification
- Class II
- Recalling firm
- Apotex Corp.
- Product quantity
- 82,375 bottles
- Reason for recall
- Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide throughout the United States
- Recall initiation date
- Apr 26, 2023
- Initial firm notification
- Letter
- Center classification date
- May 9, 2023