FDAFDA · Food and drugs·Recall number D-1170-2023
Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC 10135-0748-01
Published September 13, 2023 · Recall initiated: August 25, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's 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
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Marlex Pharmaceuticals, Inc.
- Distributor
- Nationwide in the US.
- Lot
- E3811, expiration date 02/2025
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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