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

Recall Number: D-1031-2020

Firm: Mylan Pharmaceuticals Inc.

Classification: Class II

Status: Terminated

Report Date: 20200325

Initiation Date: 20200309

Termination Date: 20210526

Reason for Recall

Presence of particulate matter. presence of metal particles.

Product Description

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