FDAFDA · Food and drugs·Recall number D-1031-2020
Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. NDC 00378-5123-01
Published March 25, 2020 · Recall initiated: March 9, 2020
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of particulate matter. presence of metal particles.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Distributor
- Distributed Nationwide in the USA
- Lot
- Lot # 3095754, exp. date 02/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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