# FDA recall D-0475-2023

> **Endo Pharmaceuticals, Inc.** · Class II · drug recall initiated 2023-03-02.

## 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.

## Distribution

Nationwide in the USA and Puerto Rico

## Key facts

- **Recall number:** D-0475-2023
- **Recalling firm:** Endo Pharmaceuticals, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-03-02
- **Report date:** 2023-04-05
- **Termination date:** 2024-11-08

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Malvern, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0475-2023

## Citation

> AI Analytics. FDA recall D-0475-2023. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-0475-2023. Source: US FDA. Licensed CC0.

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