D-1169-2023 Class I Terminated

Recalled by Marlex Pharmaceuticals, Inc. — New Castle, DE

Recall Details

Product Type
Drugs
Report Date
September 13, 2023
Initiation Date
August 25, 2023
Termination Date
April 17, 2024
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
94/100 count bottles

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

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.

Distribution Pattern

Nationwide in the US.

Code Information

Lot # E3810, expiration date 02/2025