FDA recall D-1170-2023

Marlex Pharmaceuticals, Inc. · Class II · 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

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

Nationwide in the US.

Key facts

Status: Terminated
Initiation date: 2023-08-25
Report date: 2023-09-13
Termination date: 2024-04-17
Voluntary/Mandated: Voluntary: Firm initiated
Location: New Castle, DE, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1170-2023