Osteoporosis Medication Recalled

Endo Pharmaceuticals Inc is recalling 372938 bottles of calcitonin salmon nasal spray. According to the April 5, 2023, US Food and Drug Administration (FDA) Enforcement Report, samples of the medication were out of specification for impurities. Additionally, test results suggested the drug is subpotent.

The recall affects calcitonin salmon nasal spray, 2200 international units per ml corresponding to 200 international units/spray, 3.7-mL bottles (NDC 49884-161-11), from lots 34770301 (Exp 3/23), 34770401 (Exp 5/23), 12981201 (Exp 11/23), 13037201 (Exp 12/23), 13037301 and 13647801 (Exp 2/24), 13722101 (Exp 3/24), 13980101 and 13980001 (Exp 4/24), 14461701 and 14461801 (Exp 7/24), 14706201 (Exp 8/24), 14935601 (Exp 10/24), and 5500131A and 5500132A (Exp 3/25).

The recalled units were distributed throughout the United States and in Puerto Rico.

Endo Pharmaceuticals voluntarily initiated the recall on March 2, 2023. On March 24, 2023, the FDA designated it Class II, signaling use of the affected product could cause temporary or medically reversible adverse health consequences. A remote possibility of serious harm also exists.

Calcitonin salmon nasal spray is a prescription medication indicated for the treatment of osteoporosis in women more than 5 years past menopause when alternative treatments are not suitable.