Osteoporosis Nasal Spray Recalled

More than 82,375 bottles of Calcitonin Salmon Nasal Spray are being recalled by Apotex Corp over the presence of a foreign substance. According to the May 17, 2023, US Food and Drug Administration (FDA) Enforcement Report, a “glass splinter particle entrapped inside the pump ball seat rendered the pump inoperable.”

The recall affects Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 calcitonin salmon units per mL, 200 calcitonin salmon units per spray, 3.7-mL bottle (NDC 60505-0823-6), from lot TH5645 (Exp 1/25). The spray was manufactured by Apotex Corp, Toronto, Ontario, Canada, and was distributed throughout the United States.

Apotex Corp voluntarily initiated the recall April 26, 2023. On May 9, 2023, the FDA designated the recall Class II, communicating use of the drug may cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Calcitonin Salmon Nasal Spray is a prescription medication indicated for the treatment of postmenopausal osteoporosis in women more than 5 years postmenopause.