Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Distributed by: Marlex Pharmaceuticals, Inc.
Summary
The FDA issued a Class I for Digoxin Tablets, USP 0.125mg, 100-count bottles, Rx Only, Manufactured for/Dist by Marlex Pharmaceuticals, Inc.. Reason: 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, U.
Details
Source
Drug Recall
External ID
D-1169-2023
Action Date
2023-09-13
Status
Terminated
Category
drug
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
Lot/Code Info: Lot # E3810, expiration date 02/2025
Quantity Affected: 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.
Distribution
Nationwide in the US.
Type: Voluntary: Firm initiated
Recall Initiated: 2023-08-25
Company
New Castle, DE
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 65 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Marlex Pharmaceuticals, Inc. has 2 FDA actions in our database, including 2 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Marlex Pharmaceuticals, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Marlex Pharmaceuticals, Inc. have FDA actions?
Marlex Pharmaceuticals, Inc. has 2 FDA actions in our database, including 2 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-1169-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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