# FDA recall D-0155-2020

> **Mylan Pharmaceuticals Inc.** · Class II · drug recall initiated 2019-10-18.

## Product

Prasugrel Tablets 5 mg, 30-count bottles, Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A, NDC 0378-5185-93

## Reason for recall

Failed Dissolution Specification: Low out of specification dissolution results.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0155-2020
- **Recalling firm:** Mylan Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-10-18
- **Report date:** 2019-11-06
- **Termination date:** 2020-04-10

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0155-2020

## Citation

> AI Analytics. FDA recall D-0155-2020. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0155-2020. Source: US FDA. Licensed CC0.

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