Marlex Pharmaceuticals, Inc.: Drug Recall

Recall #D-1169-2023 · 08/25/2023

Class I: Dangerous

Recall Details

Recall Number: D-1169-2023
Classification: Class I
Product Type: Drug
Recalling Firm: Marlex Pharmaceuticals, Inc.
Status: Terminated
Date Initiated: 08/25/2023
Location: New Castle, DE, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 94/100 count bottles

Reason for Recall

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.

Product Description

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

Distribution Pattern

Nationwide in the US.

Other Recalls by Marlex Pharmaceuticals, Inc.

Class II: Risk 08/25/2023

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.

View all recalls by Marlex Pharmaceuticals, Inc. →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.