D-1169-2023 Class I Terminated
FDA drug recall D-1169-2023 was initiated by Marlex Pharmaceuticals, Inc. on August 25, 2023 and is designated Class I. 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. The recall status is terminated (terminated April 17, 2024). Affected quantity: 94/100 count bottles.
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