Reported Sep 13, 2023 · Terminated
Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc.…
Marlex Pharmaceuticals, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Marlex Pharmaceuticals, Inc. · 65 Lukens Dr · New Castle, DE · 19720-2718
Is this the product you have?
- Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only
- Manufactured for/Distributed byMarlex Pharmaceuticals, Inc. New Castle, DE NDC 10135-0748-01
- Lot codes and dates
E3811expiration date 02/2025
- Amount recalled
- 94/100 count bottles
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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