Mylan Pharmaceuticals Inc. recalls Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. N…
- Recall date
- March 9, 2020
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1031-2020
- FDA classification
- Class II
- Brand / firm
- Mylan Pharmaceuticals Inc.
- Sold / distributed
- Distributed Nationwide in the USA
Why it was recalled
Presence of particulate matter. presence of metal particles.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. NDC 00378-5123-01
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