Status
Terminated
Drug Enforcement D-1169-2023
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 I
Report Date
September 13, 2023
Termination Date
April 17, 2024
Product Information
- Product description
- Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc. New Castle, DE NDC# 10135-0747-01
- 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-1169-2023
- Event ID
- 92950
- Recall initiation date
- August 25, 2023
- Center classification date
- September 18, 2023
- Code info
- Lot # E3810, expiration date 02/2025
- More code info
- —