# FDA recall D-1111-2015

> **Mylan Lab Inc** · Class II · drug recall initiated 2015-05-20.

## Product

Mycophenolic Acid Delayed-release Tablets, 180 mg, 120-count bottle, Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A., NDC 0378-4201-78, UPC 3 0378-4201-78 7.

## Reason for recall

Failed Dissolution Specifications: Low out of specification dissolution results.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1111-2015
- **Recalling firm:** Mylan Lab Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2015-05-20
- **Report date:** 2015-06-10
- **Termination date:** 2016-10-21

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1111-2015

## Citation

> AI Analytics. FDA recall D-1111-2015. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-1111-2015. Source: US FDA. Licensed CC0.

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