CALCITONIN SALMON
Generic: CALCITONIN SALMON
Sagent PharmaceuticalsManufacturer
INTRAMUSCULAR, SUBCUTANEOUSRoute
CALCITONIN SALMONActive Substance
2025-07-09Original Approval
CALCITONIN SALMON is FDA application ANDA219196, sponsored by SAGENT. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.
Recalls
Class II2023-03-02
Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 International Units/spray, 3.7 Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results f
Class II2023-04-26
Calcitonin Salmon (synthetic origin) Nasal Spray, 2200 USP Calcitonin Salmon Units/mL, 200 USP Calcitonin Salmon Units/sPresence of Foreign Substance: Glass splinter particle entrapped inside the pump ball seat rendered
Top Reported Reactions
1
DRUG INEFFECTIVE
115 reports
2
PRODUCT DOSE OMISSION ISSUE
66 reports
3
NAUSEA
53 reports
4
PAIN
50 reports
5
HEADACHE
41 reports
6
BACK PAIN
40 reports
7
OFF LABEL USE
39 reports
8
PRODUCT DELIVERY MECHANISM ISSUE
39 reports
9
FALL
38 reports
10
FATIGUE
38 reports