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
Status | Ongoing |
Mandated? | Voluntary: Firm initiated |
Recall Number | D-1170-2023 |
Event ID | 92950 |
Distribution | Nationwide in the US. |
Quantity | 94/100 count bottles |
Recall Reason | 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. |
Drug Classification | Class II |
Drug Code Info | 20230913 |
Recall Initiation Date | 20230825 |
Report Date | 20230913 |
Classification Date | 20230918 |
Address | 65 Lukens Dr New Castle, DE 19720-2718 United States |
Recalling Firm | Marlex Pharmaceuticals, Inc. |
Initial Notification | Letter |
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