Why it was recalled
Presence of particulate matter. presence of metal particles.
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
Lot numbers, UPCs & expiration codes
Lot # 3095754, exp. date 02/2021
Where it was sold
Distributed Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1031-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 9, 2020
- FDA report date
- Mar 25, 2020
- Quantity
- 300 100-count bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Mylan Pharmaceuticals Inc.
Original FDA data
Every field from FDA enforcement report D-1031-2020, exactly as published.
Show all FDA fields
- City
- Morgantown
- State
- WV
- Status
- Terminated
- Country
- United States
- Event ID
- 85152
- Address
- 781 Chestnut Ridge Rd
- Code information
- Lot # 3095754, exp. date 02/2021
- Postal code
- 26505-2730
- Report date
- Mar 25, 2020
- Product type
- Drugs
- Recall number
- D-1031-2020
- Classification
- Class II
- Recalling firm
- Mylan Pharmaceuticals Inc.
- Product quantity
- 300 100-count bottles
- Termination date
- May 26, 2021
- Reason for recall
- Presence of particulate matter. presence of metal particles.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Mar 9, 2020
- Initial firm notification
- Letter
- Center classification date
- Mar 18, 2020