Status
Completed
Drug Enforcement D-0568-2023
Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.
Classification
Class II
Report Date
May 17, 2023
Termination Date
—
Product Information
- 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
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide throughout the United States
Location & Firm
- Recalling firm
- Apotex Corp.
- Address
-
2400 N Commerce Pkwy Ste 400, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0568-2023
- Event ID
- 92208
- Recall initiation date
- April 26, 2023
- Center classification date
- May 9, 2023
- Code info
- Lot #: TH5645, Exp. 01/2025
- More code info
- —