# FDA recall D-0441-2017

> **Mylan LLC.** · Class II · drug recall initiated 2016-12-20.

## Product

Temozolomide Capsules, 100 mg, packaged in a) 5-count bottles (NDC 0378-5262-98), b) 14-count bottles (NDC 0378-5262-14), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 USA.

## Reason for recall

Failed Tablet/Capsule Specifications: customer complaints of broken or crushed capsules, resulting in loose powder in the bottle.

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0441-2017
- **Recalling firm:** Mylan LLC.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-12-20
- **Report date:** 2017-02-01
- **Termination date:** 2018-01-25

- **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-0441-2017

## Citation

> AI Analytics. FDA recall D-0441-2017. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0441-2017. Source: US FDA. Licensed CC0.

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