Calcitonin Salmon Nasal Spray — Class II drug recall D-0475-2023
Terminated recall by Endo Pharmaceuticals, Inc., reported 2023-04-05, distributed nationwide. Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known
| Recall number | D-0475-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Endo Pharmaceuticals, Inc., Malvern, PA, United States |
| Recall initiated | 2023-03-02 |
| Classified | 2023-03-24 |
| Reported by FDA | 2023-04-05 |
| Terminated | 2024-11-08 |
| Distributed | Nationwide (US) |
| Quantity | 372,938 bottles |
| Reason classes | potency, specification failure |
| NDC | 49884-0161, 49884-0161-11 |
| Lot numbers | 12981201, 13037201, 13037301, 13647801, 13722101, 13980001, 13980101, 14461701, 14461801, 14706201, 14935601, 34770301, 34770401, 5500131A, 5500132A, APR-24, AUG-24, DEC-23, FEB-24, JUL-24, MAR-23, MAR-24, MAR-25, MAY-23, NOV-23, OCT-24 |
Product
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.
Reason for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0475-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.