FDA recall D-1169-2023

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

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-1169-2023