Medications & Supplements/Prescription Drugs

Mylan Pharmaceuticals Inc.: Sotalol HCL Tablets Recalled Due to Metal Particles

Agency Publication Date: March 18, 2020

Summary

Mylan Pharmaceuticals Inc. has recalled approximately 300 bottles of Sotalol HCL Tablets, USP (AF) 80 mg, a prescription heart medication. The recall was initiated because the tablets may contain foreign particulate matter, specifically metal particles. This contamination was discovered during the manufacturing process and affects 100-count bottles that were distributed nationwide throughout the United States.

Risk

Ingesting medication contaminated with metal particles can cause internal irritation or injury to the digestive tract. The presence of these particles may also affect the chemical stability and efficacy of the medication, potentially compromising the treatment of heart rhythm conditions.

What You Should Do

Locate your Sotalol HCL Tablets, USP (AF) 80 mg (100-count bottles) and check the label for NDC 00378-5123-01.
Check the packaging for Lot # 3095754 with an expiration date of 02/2021 to see if your bottle is part of the recall.
If you have an affected bottle, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a safe replacement.
Return any unused medication from the affected lot to your pharmacy for a refund and further instructions.
Contact Mylan Pharmaceuticals Inc. at their headquarters (781 Chestnut Ridge Rd, Morgantown, WV 26505) or through their standard customer service channels for additional information regarding this recall.
For general questions about drug safety and recalls, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare consultation and pharmacy return

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Sotalol HCL Tablets, USP (AF) 80 mg (100-count bottle)

Model:

NDC 00378-5123-01

Recall #: D-1031-2020

Lot Numbers:

3095754 (Exp 02/2021)

Date Ranges: 02/2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 85152

Status: Resolved

Manufacturer: Mylan Pharmaceuticals Inc.

Sold By: pharmacies

Manufactured In: United States

Units Affected: 300 100-count bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

Locate your Sotalol HCL Tablets, USP (AF) 80 mg (100-count bottles) and check the label for NDC 00378-5123-01.

Check the packaging for Lot # 3095754 with an expiration date of 02/2021 to see if your bottle is part of the recall.

If you have an affected bottle, contact your healthcare provider or pharmacist immediately to discuss your treatment and obtain a safe replacement.

Return any unused medication from the affected lot to your pharmacy for a refund and further instructions.

Contact Mylan Pharmaceuticals Inc. at their headquarters (781 Chestnut Ridge Rd, Morgantown, WV 26505) or through their standard customer service channels for additional information regarding this recall.

For general questions about drug safety and recalls, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.