# FDA recall D-0378-2015

> **Mylan Institutional, Inc. (d.b.a. UDL Laboratories)** · Class II · drug recall initiated 2013-09-26.

## Product

LAMOTRIGINE TABLETS, 200 mg, 100 Tablets (10 tablets per blister card x 10 blister cards per carton), Rx only,  Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV ---  NDC 51079-866-20

## Reason for recall

CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices

## Distribution

Nationwide and Puerto Rico.

## Key facts

- **Recall number:** D-0378-2015
- **Recalling firm:** Mylan Institutional, Inc. (d.b.a. UDL Laboratories)
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2013-09-26
- **Report date:** 2015-01-28
- **Termination date:** 2015-11-09

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Rockford, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0378-2015

## Citation

> AI Analytics. FDA recall D-0378-2015. Retrieved 2026-06-05 from https://api.ai-analytics.org/recall/D-0378-2015. Source: US FDA. Licensed CC0.

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