Drug recall: Digoxin Tablets recalled due to label mix-up

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Drug recall
Drug recall

Last Updated on October 15, 2024 by The Health Master

Drug recall

Drug recall: In New Castle, Delaware, Marlex Pharmaceuticals, Inc. is voluntarily recalling one lot of Digoxin Tablets USP, 0.125 mg, and one lot of Digoxin Tablets USP, 0.25 mg, to the consumer level due to a label mix-Up.

  • Bottles of Digoxin Tablets, USP 0.125mg, are incorrectly labeled and contain Digoxin Tablets, USP, 0.25mg.
  • Bottles of Digoxin Tablets USP, 0.25 mg, are incorrectly labeled and contain Digoxin Tablets USP, 0.125mg.
  • Digoxin Tablets USP, 0.125 mg, are yellow, circular, beveled, uncoated tablets scored between “N” and “201” on one side and plain on the other side.
  • Digoxin Tablets USP, 0.25 mg, are white to off-white, circular. beveled, uncoated tablets scored between “N” and “202” on one side and plain on the other side.

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 take Digoxin 0.25 mg, will 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 a potential heart failure exacerbation.

Marlex Pharmaceuticals, Inc. has not received any reports of adverse events related to this recall.

Product usage

  • 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.

Product details

The product is packaged as 100 tablets in white HDPE bottles and labeled as indicated below with the 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

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration (FDA).

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