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FDAAugust 25, 2023drug

Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC# 10135-0747-01

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets, USP 0.25mg and bottles labeled as Digoxin Tablets, USP 0.25mg contain Digoxin Tablets, USP 0.125mg.

What to do

FDA enforcement status: Terminated

Brands named

marlex pharmaceuticalsmarlex

UPCs

10135074701

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC# 10135-0747-01 — Recall Details · AllClear