Safety Report: Marlex Pharmaceuticals Digoxin Tablets USP - recalled due to Label Mix-Up, USA

United States

Marlex Pharmaceuticals, Inc. is voluntarily recalling one lot of Digoxin Tablets USP, 0.125mg and one lot of Digoxin Tablets USP, 0.25mg to the consumer level due to Label Mix-Up. Bottles of Digoxin Tablets, USP 0.125mg s are incorrectly labeled and contain Digoxin Tablets USP, 0.25mg Tablets. Bottles of Digoxin Tablets USP, 0.25mg are incorrectly labeled and contain Digoxin Tablets USP, 0.125mg. These products were distributed Nationwide. Marlex Pharmaceuticals, Inc has not received any reports of adverse events related to this recall.

Digoxin Tablets USP, 0.125mg are yellow, circular, beveled, uncoated tablets scored between "N" and "201" on one side and plain on the other side.
Digoxin Tablets USP, 0.25mg are white to off-white, circular. beveled, uncoated tablets scored between "N" and "202" on one side and plain on the other side.

The product is packaged as 100 tablets in white HDPE bottles and labeled as indicated below with NDC, lot and expiration date. Digoxin 0.125mg Tablet – NDC 10135-0747-01, lot# E3810, expiration 2/2025 Digoxin 0.25mg Tablet – NDC 10135-0748-01, lot# E3811, expiration 2/2025 Digoxin Tablets USP, 0.125mg and Digoxin Tablets USP, 0.25mg

Risk Statement: The mix-up in labels can cause either overdosing or underdosing in patients who unknowingly take the wrong dose. Patients who intend to take Digoxin Tablets USP, 0.125mg, but unknowingly Digoxin 0.25mg would receive a super potent dose and can experience significant drug toxicity (mental disorientation, dizziness, blurred vision, memory loss and fainting) from the unintentional overdose. Patients who intend to take Digoxin Tablets USP, 0.25mg, but unknowingly take Digoxin 0.125mg would receive a sub potent dose which may lead to loss of control of heart rate and potential heart failure exacerbation.

The product is used for the treatment of mild to moderate heart failure. Digoxin increases heart muscle contraction in pediatric patients with heart failure. Digoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation.

Consumers/distributors/retailers that have Digoxin Tablets USP, 0.125mg and Digoxin Tablets USP, 0.25mg (lot# E3810 and lot# E3811) which are being recalled should stop using/return to place of purchase.

Marlex Pharmaceuticals, Inc. is notifying its distributors and customers by emails and is arranging for return of all recalled products (lot# E3810 and lot# E3811).

In case you experience harm from these products, it is important to report it. It can help to detect & resolve issues and prevent others from being harmed, and it enables better surveillance. If symptoms persist, seek medical care.

Company name: Marlex Pharmaceuticals, Inc.
Brand name: Marlex Pharmaceuticals, Inc.
Product recalled: Digoxin Tablets USP, 0.125mg and 0.25mg
Reason of the recall: Label Mix-Up
FDA Recall date: August 31, 2023

Source: www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/marlex-pharmaceuticals-inc-issues-voluntary-nationwide-recall-digoxin-tablets-usp-0125mg-and-digoxin