Skip to content
Recall Observatory FDA recall evidence

Drug product

Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC 10135-0748-01

D-1170-2023

August 25, 2023

Class II

Product summary

Firm
Marlex Pharmaceuticals, Inc.
Event
Event 92950
Status
Terminated
Classification
Class II
Quantity
94/100 count bottles
Official record key
drug-enforcement:D-1170-2023

Official wording

Reason: 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.

Code information: E3811, expiration date 02/2025

Distribution pattern: Nationwide in the US.

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Mix-Up