US Drug Recall Register
Class II · Moderate risk Terminated Initiated Mar 2, 2023 (4 years ago)

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.