Drug recall D-1031-2020

Class II Terminated reported Mar 25, 2020

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.

Lots and codes

Lot # 3095754, exp. date 02/2021

Recall details

Recalling firm
Mylan Pharmaceuticals Inc., Morgantown, WV
Quantity
300 100-count bottles
Distribution
Distributed Nationwide in the USA
Type
Voluntary: Firm initiated
Recall initiated
March 9, 2020
Terminated
May 26, 2021