# FDA recall D-066-2013

> **Mylan LLC.** · Class II · drug recall initiated 2012-06-29.

## Product

Mylan, Tacrolimus Capsules 0.5 mg, 100 count bottle, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 NDC 0378-2045-01

## Reason for recall

Failed USP Content Uniformity Requirements: OOS result reported on retained samples.

## Distribution

Natiowide

## Key facts

- **Recall number:** D-066-2013
- **Recalling firm:** Mylan LLC.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2012-06-29
- **Report date:** 2012-12-05
- **Termination date:** 2017-04-13

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Caguas, PR, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-066-2013

## Citation

> AI Analytics. FDA recall D-066-2013. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-066-2013. Source: US FDA. Licensed CC0.

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