A recall of Calcitonin Salmon Nasal Spray, USP was initiated on March 2, 2023. The FDA classified this action as a Class II recall.
The recalled product is described as Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL, corresponding to 200 International Units per spray, in a 3.7 mL bottle, Rx only. It carries NDC 49884-161-11 and was manufactured by Par Pharmaceutical in Chestnut Ridge, NY.
According to the recall record, the reason cited was failure to meet impurities and degradation specifications. The report states there were high out of specification results for a known and unknown impurity. It also notes low out of specification results for assay, described as a subpotent drug issue.
Endo Pharmaceuticals, Inc. is listed as the recalling firm. The recall status is listed as terminated.
This information reflects the details contained in the FDA recall record for this event. Readers seeking general information about calcitonin can consult the compound overview for further context.</body_markdown>
<parameter name="sources">["https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts"]