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
Reported: May 17, 2023 Initiated: April 26, 2023 #D-0568-2023
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.
Details
- Recalling Firm
- Apotex Corp.
- Units Affected
- 82,375 bottles
- Distribution
- Nationwide throughout the United States
- Location
- Weston, FL
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.
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