Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. NDC 00378-5123-01
Reported: March 25, 2020 Initiated: March 9, 2020 #D-1031-2020
Product Description
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.
Details
- Recalling Firm
- Mylan Pharmaceuticals Inc.
- Units Affected
- 300 100-count bottles
- Distribution
- Distributed Nationwide in the USA
- Location
- Morgantown, WV
Frequently Asked Questions
What product 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. Recalled by Mylan Pharmaceuticals Inc.. Units affected: 300 100-count bottles.
Why was this product recalled? ▼
Presence of particulate matter. presence of metal particles.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on March 25, 2020. Severity: Moderate. Recall number: D-1031-2020.
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