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The United States: Marlex Pharmaceuticals, Inc. issues voluntary nationwide recall of Digoxin Tablets USP, 0.125mg and Digoxin Tablets USP, 0.25mg due to label mix-up (English only)
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The US Food and Drug Administration (FDA) announces that Marlex Pharmaceuticals, Inc. is voluntarily recalling one lot of Digoxin Tablets USP, 0.125mg (lot number: E3810) and one lot of Digoxin Tablets USP, 0.25mg (lot number: E3811) to the consumer level due to 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, 0.25mg are incorrectly labeled and contain Digoxin Tablets USP, 0.125mg. 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 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. Marlex Pharmaceuticals, Inc. has not received any reports of adverse events related to this recall. Please refer to the following website in FDA for details: http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/marlex-pharmaceuticals-inc-issues-voluntary-nationwide-recall-digoxin-tablets-usp-0125mg-and-digoxin In Hong Kong, the above products are not registered pharmaceutical products. Ends/Monday, Sep 4, 2023 Issued at HKT 15:30

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