# FDA recall D-0279-2025

> **Slate Run Pharmaceuticals** · Class II · drug recall initiated 2025-03-07.

## Product

Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by: Piramal Pharma Limited, Madhya Pradesh, India, NDC 70436-008-04

## Reason for recall

CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.

## Distribution

Product was distributed to 8 distributors who may have further distribute the product nationwide.

## Key facts

- **Recall number:** D-0279-2025
- **Recalling firm:** Slate Run Pharmaceuticals
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-03-07
- **Report date:** 2025-03-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Columbus, OH, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0279-2025

## Citation

> AI Analytics. FDA recall D-0279-2025. Retrieved 2026-07-07 from https://api.ai-analytics.org/recall/D-0279-2025. Source: US FDA. Licensed CC0.

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