Marlex Pharmaceuticals, Inc. recalls Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc.…
- Recall date
- August 25, 2023
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- D-1170-2023
- FDA classification
- Class II
- Brand / firm
- Marlex Pharmaceuticals, Inc.
- Sold / distributed
- Nationwide in the US.
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.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC 10135-0748-01
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