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Label Mix Up Leads to Recall of Digoxin

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The mix-up in labels can cause either overdosing or underdosing in patients who unknowingly take the wrong dose. Digoxin is used to treat patients with heart failure and chronic atrial fibrillation.

Marlex Pharmaceuticals is recalling one lot of Digoxin Tablets, 0.125 mg and one lot of Digoxin Tablets, 0.25 mg to because of a label mix-up. Bottles of digoxin 0.125 mg are incorrectly labeled and contain digoxin 0.25 mg tablets. Bottles of digoxin 0.25 mg are incorrectly labeled and contain digoxin 0.125 mg.

Digoxin is used to treat patients with mild-to-moderate heart failure and chronic atrial fibrillation. The mix-up in labels can cause either overdosing or underdosing in patients who unknowingly take the wrong dose. Patients who unknowingly digoxin 0.25 mg 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 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.

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

The two lots involved in the recall (labels below):

  • Digoxin 0.125 mg Tablet with an NDC 10135-0747-01, lot# E3810. It has an expiration date of February 2025
  • Digoxin 0.25 mg Tablet with NDC 10135-0748-01, lot# E3811. It has an expiration date of February 2025

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