Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC 10135-0748-01
Reported: September 13, 2023 Initiated: August 25, 2023 #D-1170-2023
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
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.
Details
- Recalling Firm
- Marlex Pharmaceuticals, Inc.
- Units Affected
- 94/100 count bottles
- Distribution
- Nationwide in the US.
- Location
- New Castle, DE
Frequently Asked Questions
What product was recalled? ▼
Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC 10135-0748-01. Recalled by Marlex Pharmaceuticals, Inc.. Units affected: 94/100 count bottles.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 13, 2023. Severity: Moderate. Recall number: D-1170-2023.
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