Class II
Terminated
Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC 10135-0748-01
This recall has been terminated (originally issued September 13, 2023).
- Company
- Marlex Pharmaceuticals, Inc.
- Recall Initiated
- August 25, 2023
- Posted
- September 13, 2023
- Recall Number
- D-1170-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 94/100 count bottles
- Firm Location
- New Castle, DE, United States
- Official Source
- View on FDA website ↗
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.
Lot / Code Info
E3811, expiration date 02/2025
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