Status
Terminated
Drug Enforcement D-1170-2023
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.
Classification
Class II
Report Date
September 13, 2023
Termination Date
April 17, 2024
Product Information
- 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
- Product quantity
- 94/100 count bottles
- 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 initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the US.
Location & Firm
- Recalling firm
- Marlex Pharmaceuticals, Inc.
- Address
-
65 Lukens Dr, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-1170-2023
- Event ID
- 92950
- Recall initiation date
- August 25, 2023
- Center classification date
- September 18, 2023
- Code info
- E3811, expiration date 02/2025
- More code info
- —