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Warning letters, 483s, Recalls, Import Alerts, Audit observations
Bottles of Digoxin Tablets, USP 0.125mg are incorrectly labelled and contain Digoxin Tablets USP, 0.25mg Tablets. Bottles of Digoxin Tablets USP, 0.25mg are incorrectly labelled and contain Digoxin Tablets USP, 0.125mg. The mix-up in labels can cause either overdosing or underdosing in patients who unknowingly take the wrong dose. Digoxin is used for treatment of mild to moderate heart failure in paediatric patients as well as adults. The recalled product is manufactured and distributed by Marlex Pharmaceuticals, New Castle, USA.
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