Marlex Pharmaceuticals, Inc. recalls Digoxin Tablets, USP 0.125mg, 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-1169-2023

FDA classification

Class I

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 I is the FDA’s most serious recall level: there is a reasonable probability that using this product will cause serious harm or death.

What was recalled

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