FDA Recall D-1169-2023
Marlex Pharmaceuticals, Inc. · New Castle, DE
Class I — life-threatening Terminated 236 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
Product
Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC# 10135-0747-01
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.
Recall record
- Recall number
D-1169-2023- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide in the US.
- Recall initiated
- 2023-08-25
- Classified by FDA Center
- 2023-09-18
- FDA published
- 2023-09-13
- Terminated
- 2024-04-17
- Recalling firm
- Marlex Pharmaceuticals, Inc.
- Firm location
- New Castle, DE