Recalls / Class II
Class IID-1031-2020
Product
Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. NDC 00378-5123-01
- Affected lot / code info
- Lot # 3095754, exp. date 02/2021
Why it was recalled
Presence of particulate matter. presence of metal particles.
Recalling firm
- Firm
- Mylan Pharmaceuticals Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 781 Chestnut Ridge Rd, Morgantown, West Virginia 26505-2730
Distribution
- Quantity
- 300 100-count bottles
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2020-03-09
- FDA classified
- 2020-03-18
- Posted by FDA
- 2020-03-25
- Terminated
- 2021-05-26
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1031-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.