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
D-1031-2020
Product summary
- Event
- Event 85152
- Status
- Terminated
- Classification
- Class II
- Quantity
- 300 100-count bottles
- Official record key
drug-enforcement:D-1031-2020
Official wording
Reason: Presence of particulate matter. presence of metal particles.
Code information: Lot # 3095754, exp. date 02/2021
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Foreign material or chemical contamination
particulate matter