FDA recall D-1031-2020
Mylan Pharmaceuticals Inc. · Class II · drug
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
- 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
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1031-2020