# FDA recall D-1031-2020

> **Mylan Pharmaceuticals Inc.** · Class II · drug recall initiated 2020-03-09.

## Product

Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. NDC 00378-5123-01

## Reason for recall

Presence of particulate matter. presence of metal particles.

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-1031-2020
- **Recalling firm:** Mylan Pharmaceuticals Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-03-09
- **Report date:** 2020-03-25
- **Termination date:** 2021-05-26

- **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-1031-2020

## Citation

> AI Analytics. FDA recall D-1031-2020. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1031-2020. Source: US FDA. Licensed CC0.

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