D-1031-2020 Class II Terminated
FDA drug recall D-1031-2020 was initiated by Mylan Pharmaceuticals Inc. on Mar 9, 2020 and is designated Class II. Reason for recall: Presence of particulate matter. presence of metal particles. The recall status is terminated (terminated May 26, 2021). Affected quantity: 300 100-count bottles.
Recall details
- Product Type
- Drugs
- Report Date
- Mar 25, 2020
- Initiation Date
- Mar 9, 2020
- Termination Date
- May 26, 2021
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 300 100-count bottles
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.
Distribution pattern
Distributed Nationwide in the USA
Code information
Lot # 3095754, exp. date 02/2021
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1031-2020
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026