Elevated risk U.S. Food and Drug Administration

Marlex Pharmaceuticals Digoxin Tablets USP, 0.125mg and 0.25mg recall: Label Mix-Up

Recall published 3+ years ago

Label Mix-Up

Marlex Pharmaceuticals Prescription & OTC drugs — recalled prescription & otc drugsMarlex Pharmaceuticals Prescription & OTC drugs — recalled prescription & otc drugs (photo 2)
2 photos published by U.S. Food and Drug Administration with the recall notice.

The hazard: Labelling or manufacturing-practice failure

The defect here is documentary: wrong strength on the label, a mismatched barcode, or records that do not demonstrate the product was made correctly.

What the notice says: Risk Statement: The mix-up in labels can cause either overdosing or underdosing in patients who unknowingly take the wrong dose.

Why it matters: The label, the strength printed on it, the barcode or the manufacturing records do not meet federal requirements. The practical danger is someone taking the wrong drug or the wrong dose while believing they have the right one.

Symptoms and when to call a doctor

If you may have taken a product that turned out to be a different drug or strength from the one on the label, call your prescriber, and call Poison Control on 1-800-222-1222 if you feel unwell. Describe what the pack said and what you actually took.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Published
August 30, 2023
Risk level
Elevated risk
Issued by
U.S. Food and Drug Administration
Brand
Marlex Pharmaceuticals
Product type
Prescription & OTC drugs
Distribution
Nationwide

Products covered by this recall

Digoxin Tablets USP, 0.125mg and 0.25mg

What the company announced

FOR IMMEDIATE RELEASE – August 30, 2023 – New Castle, Delaware , Marlex Pharmaceuticals, Inc. is voluntarily recalling one lot of Digoxin Tablets USP, 0.125mg and one lot of Digoxin Tablets USP, 0.25mg to the consumer level due to Label Mix-Up. Bottles of Digoxin Tablets, USP 0.125mg s are incorrectly labeled and contain Digoxin Tablets USP, 0.25mg Tablets. Bottles of Digoxin Tablets USP, 0.25mg are incorrectly labeled and contain Digoxin Tablets USP, 0.125mg.

Digoxin Tablets USP, 0.125mg are yellow, circular, beveled, uncoated tablets scored between "N" and "201" on one side and plain on the other side.

Digoxin Tablets USP, 0.25mg are white to off-white, circular. beveled, uncoated tablets scored between "N" and "202" on one side and plain on the other side.

Risk Statement: The mix-up in labels can cause either overdosing or underdosing in patients who unknowingly take the wrong dose. Patients who intend to take Digoxin Tablets USP, 0.125mg, but unknowingly Digoxin 0.25mg would receive a super potent dose and can experience significant drug toxicity (mental disorientation, dizziness, blurred vision, memory loss and fainting) from the unintentional overdose. Patients who intend to take Digoxin Tablets USP, 0.25mg, but unknowingly take Digoxin 0.125mg would receive a sub potent dose which may lead to loss of control of heart rate and potential heart failure exacerbation. Marlex Pharmaceuticals, Inc has not received any reports of adverse events related to this recall.

The product is used for the treatment of mild to moderate heart failure. Digoxin increases heart muscle contraction in pediatric patients with heart failure. Digoxin is indicated for the control of ventricular response rate in adult patients with chronic atrial fibrillation. The product is packaged as 100 tablets in white HDPE bottles and labeled as indicated below with NDC, lot and expiration date.

Digoxin 0.125mg Tablet – NDC 10135-0747-01, lot# E3810, expiration 2/2025

Digoxin 0.25mg Tablet – NDC 10135-0748-01, lot# E3811, expiration 2/2025

Digoxin Tablets USP, 0.125mg and Digoxin Tablets USP, 0.25mg Product were distributed Nationwide.

Consumers/distributors/retailers that have Digoxin Tablets USP, 0.125mg and Digoxin Tablets USP, 0.25mg (lot# E3810 and lot# E3811) which are being recalled should stop using/return to place of purchase . Marlex Pharmaceuticals, Inc. is notifying its distributors and customers by emails and is arranging for return of all recalled products (lot# E3810 and lot# E3811) .

Consumers with questions regarding this recall can contact Marlex Pharmaceuticals, Inc. by phone number 302-328-3355 or toll free 888-582-1953 on Monday - Friday from 8.30AM and 4:30PM, EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Complete and submit the report Online

Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Reproduced from the company announcement posted on fda.gov. Links and contact forms in the original are not repeated here; the official notice below has them.

Check your product

The notice names 11 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 0.125mg
  • 0.25mg
  • E3810
  • E3811

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 2/2025
  • 0.125mg

Establishment number

Inside the USDA mark of inspection on the label.

  • 201
  • 202

NDC number

On the carton and again on the bottle or blister label.

  • 10135-0747-01
  • 10135-0748-01

Package size

Match the net weight or the piece count on the front of the pack.

  • 0.25 mg

Codes are lifted verbatim from the FDA — Company recall announcements notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Labelling

Marlex Pharmaceuticals — The defect here is documentary: wrong strength on the label, a mismatched barcode, or records that do not demonstrate the product was made correctly.

  1. Compare the lot number and strength on your pack with the codes above and with what your prescription actually says.
  2. Return the affected pack to the pharmacy for a replacement from a good lot.
  3. Report a mismatch to FDA MedWatch, especially if it reached you rather than being caught at the counter.
  4. If what you were dispensed does not match your prescription, call the pharmacy before taking another dose.

What the company owes you

A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.

  • The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
  • Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
  • Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
  • Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.

Company contact: Marlex Pharmaceuticals, Inc. — Consumers: Marlex Pharmaceuticals, Inc, 302-328-3355 or toll free 888-582-1953

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Company recall announcements record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Marlex Pharmaceuticals prescription & otc drugs recalled?

Label Mix-Up Risk Statement: The mix-up in labels can cause either overdosing or underdosing in patients who unknowingly take the wrong dose.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 0.125mg, 0.25mg, E3810; best-by date 2/2025 or 0.125mg; establishment number 201, 202. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Compare the lot number and strength on your pack with the codes above and with what your prescription actually says.

Can I get my money back?

The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.

Where was the recalled product sold?

It was distributed nationwide.

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