# FDA recall D-1217-2015

> **Mylan Pharmaceuticals Inc** · Class II · drug recall initiated 2015-06-30.

## Product

Capecitabine Tablets, USP, 500 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505, NDC 0378-2512-78, UPC 3 0378-2512-78 6.

## Reason for recall

Failed Dissolution Specifications: low out-of-specification (OOS) results for dissolution were obtained at the nine-month stability point.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1217-2015
- **Recalling firm:** Mylan Pharmaceuticals Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-06-30
- **Report date:** 2015-07-15
- **Termination date:** 2016-09-22

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1217-2015

## Citation

> AI Analytics. FDA recall D-1217-2015. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1217-2015. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*