Calcitonin Salmon Nasal Spray
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low Out of Specification results for assay.
What was recalled
Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 International Units/spray, 3.7 mL bottle, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 49884-161-11.
- Recalling firm
- Endo Pharmaceuticals, Inc.
- NDC code
- 49884-161-11
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0475-2023
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
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