D-0568-2023 Class II
FDA drug recall D-0568-2023 was initiated by Apotex Corp. on Apr 26, 2023 and is designated Class II. Reason for recall: Presence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable. Affected quantity: 82,375 bottles.
Recall details
- Product Type
- Drugs
- Report Date
- May 17, 2023
- Initiation Date
- Apr 26, 2023
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product 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
Code information
Lot #: TH5645, Exp. 01/2025
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0568-2023
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026