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Class II: temporary or reversible health riskTerminated

Marlex Pharmaceuticals Digoxin Tablets Recall

Digoxin Tablets, USP 0

Marlex Pharmaceuticals, Inc. · New Castle, DE

Risk level
Class II
Reported by FDA
Sep 13, 2023
Recall ID
D-1170-2023
Check your lot numberHow we source this data

Summary

Marlex Pharmaceuticals recalled Digoxin Tablets starting Aug 25, 2023. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-1170-2023 on Sep 13, 2023. 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, USP 0.25mg contain Digoxin Tablets, USP 0.125mg. Status: Terminated.

Why it was 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.

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

Lot numbers, UPCs & expiration codes

E3811, expiration date 02/2025

Where it was sold

Nationwide in the US.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-1170-2023
Classification
Class II
Status
Terminated
Recall initiated
Aug 25, 2023
FDA report date
Sep 13, 2023
Quantity
94/100 count bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Marlex Pharmaceuticals, Inc.

Original FDA data

Every field from FDA enforcement report D-1170-2023, exactly as published.

Show all FDA fields
City
New Castle
State
DE
Status
Terminated
Country
United States
Event ID
92950
Address
65 Lukens Dr
Code information
E3811, expiration date 02/2025
Postal code
19720-2718
Report date
Sep 13, 2023
Product type
Drugs
Recall number
D-1170-2023
Classification
Class II
Recalling firm
Marlex Pharmaceuticals, Inc.
Product quantity
94/100 count bottles
Termination date
Apr 17, 2024
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.
Voluntary / mandated
Voluntary: Firm initiated
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
Distribution pattern
Nationwide in the US.
Recall initiation date
Aug 25, 2023
Initial firm notification
Letter
Center classification date
Sep 18, 2023

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1170-2023, published Sep 13, 2023. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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