US Drug Recall Register
Class II · Moderate risk Terminated Initiated Mar 9, 2020 (6 years ago)

Sotalol HCL Tablets

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Presence of particulate matter. presence of metal particles.

What was recalled

Sotalol HCL Tablets, USP (AF) 80 mg, 100 count bottles, Rx Only, Mylan Pharmaceuticals Inc. Morgantown, WV 26505 USA. NDC 00378-5123-01

Recalling firm
Mylan Pharmaceuticals Inc.
NDC code
00378-5123-01
Origin
WV, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1031-2020

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

Other Sotalol recalls

See all
Class II · Moderate risk Terminated

Sotalol HCL

Reason Labeling: Label Mixup: SOTALOL HCL, Tablet, 160 mg may have potentially been mislabeled as the following drug: DISULFIRAM, Tablet, 250 mg, NDC 64980017101, Pedigree: AD22609_1, EXP: 5/2/2014.

Aidapak Services, LLC D-834-2014
Class II · Moderate risk Terminated

Sotalol HCL

Reason Labeling: Label Mixup: SOTALOL HCL, Tablet, 80 mg may have potentially been mislabeled as one of the following drugs: DILTIAZEM HCL, Tablet, 120 mg, NDC 00093032101, Pedigree: AD30197_1, EXP: 5/9/2014; PROPRANOLOL HCL ER, Capsule, 60 mg, NDC 00228277811, Pedigree: AD54605_4, EXP: 5/20/2014.

Aidapak Services, LLC D-833-2014
Class II · Moderate risk Terminated

Sotalol HCL

Reason Labeling: Label Mixup: SOTALOL HCL, Tablet, 120 mg may have potentially been mislabeled as the following drug: NEOMYCIN SULFATE, Tablet, 500 mg, NDC 51991073801, Pedigree: AD49448_17, EXP: 5/17/2014.

Aidapak Services, LLC D-832-2014