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Recall D-1170-2023

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

Recall D-1170-2023 Information

Mandated?Voluntary: Firm initiated
Recall NumberD-1170-2023
Event ID92950
DistributionNationwide in the US.
Quantity94/100 count bottles
Recall ReasonLabeling: 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.
Drug ClassificationClass II
Drug Code Info20230913
Recall Initiation Date20230825
Report Date20230913
Classification Date20230918
Address65 Lukens Dr
New Castle, DE 19720-2718
United States
Recalling FirmMarlex Pharmaceuticals, Inc.
Initial Notification Letter
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