Mylan Recalls Sotalol HCL Tablets Due to Metal Particles
Mylan Pharmaceuticals is recalling Sotalol HCL 80 mg tablets because of the presence of metal particles. The affected lot was distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the presence of metal particles in oral medication represents a significant injury risk, meeting the criteria for a Severe rating.
Plain-English summary
Mylan Pharmaceuticals Inc. is recalling 300 bottles of Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles. The recall is due to the presence of particulate matter, specifically metal particles, in the product.
The affected product is identified by Lot # 3095754 with an expiration date of 02/2021. The NDC number is 00378-5123-01. The product was distributed nationwide in the USA.
Consumers should check their medication for the specific lot number and expiration date. If they have the affected product, they should stop using it and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. NDC 00378-5123-01
- Manufacturer
- Mylan Pharmaceuticals Inc.
- Category
- Drug — Prescription Medication
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot # 3095754
- exp. date 02/2021
Distribution
Distributed nationwide across the United States.
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