A Class II recall of Calcitonin Salmon Nasal Spray was initiated on April 26, 2023. The recall involves the 2200 USP Calcitonin Salmon Units/mL formulation, packaged in 3.7 mL bottles delivering 200 USP Calcitonin Salmon Units per spray, NDC 60505-0823-6.
The product is manufactured by Apotex Corp. of Toronto, Ontario, Canada, and is available by prescription only.
The reason for the recall is listed as presence of a foreign substance. Specifically, a glass splinter particle was found entrapped inside the pump ball seat, rendering the pump inoperable.
The recall has been classified as Class II by regulatory records. The action status is listed as Completed.
This recall record does not describe any reported injuries or adverse events tied to the defect. The listed reason concerns pump function rather than the drug substance itself.
Calcitonin salmon remains an approved product. This brief reports only the details of this specific recall action as recorded, including its classification, stated reason, responsible firm, and initiation date.
Readers seeking general background on calcitonin can consult the compound overview for additional context.