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Recall Enforment Report D-1170-2023

Recall Details

Multi event Drug Recall Enforcement Report Class II voluntary initiated by Marlex Pharmaceuticals, Inc., originally initiated on 08-25-2023 for the 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 The product was recalled due to 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 product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-1170-202308-25-202309-13-2023Class II94/100 count bottlesDigoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC 10135-0748-01Labeling: 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.Terminated
D-1169-202308-25-202309-13-2023Class I94/100 count bottlesDigoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC# 10135-0747-01Labeling: 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.Terminated