← FDA ENFORCEMENT
D-1170-2023Class II

Marlex Pharmaceuticals, Inc.

Recalling firm
Marlex Pharmaceuticals, Inc.
Product type
Drug
Status
Terminated
Report date
2023-09-13
Distribution
Nationwide in the US.
Firm state
DE
Product quantity
94/100 count bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Documentation & Change Control
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 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC 10135-0748-01

Code / lot info

E3811, expiration date 02/2025

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.