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Recall Observatory FDA recall evidence

Drug product

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

D-1169-2023

August 25, 2023

Class I

Product summary

Firm
Marlex Pharmaceuticals, Inc.
Event
Event 92950
Status
Terminated
Classification
Class I
Quantity
94/100 count bottles
Official record key
drug-enforcement:D-1169-2023

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: Lot # E3810, 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