The FDA has announced a recall of Digoxin Tablets USP due to mislabeling that could cause patients to ingest the incorrect dosage of the popular heart drug. Some Digoxin Tablets USP 0.25mg bottles are mislabeled as Digoxin Tablets USP, 0.125mg, causing patients to take double their prescribed dosage unknowingly. Meanwhile, some bottles of Digoxin Tablets USP. 0.125mg are mislabeled as Digoxin Tablets USP, 0.25mg, causing patients to receive only half of their prescribed dosage.
SUMMARY
Date of Recall:
Announced: August 30, 2023
Public Notification: August 31, 2023
Name(s) of Drug:
Digoxin Tablets USP, 0.125mg
Digoxin Tablets USP, 0.25mg
Company Name:
Marlex Pharmaceuticals, Inc.
Drug Indication:
Heart Failure
Pediatric Heart Failure
Atrial Fibrillation
Product Description
The pills are distributed in white plastic bottles labeled with the drug name, dosage, lot number, NDC number, and expiration date. Labels are blue and white and bear the manufacturer’s name, Marlex, accented in red. The recalled medications were distributed by pharmacies nationwide.
Reason for Recall
At the time of writing this notice, the FDA has not released any information related to adverse events related to the mix-up. However, accidental mislabeling of the bottles may cause consumers to unknowingly take the incorrect dose of their medication. This act can lead to serious consequences, including death.
Impacts
Consumers who ingest the mislabeled medication will either receive a potentially dangerous dose of the medication or will receive less than is necessary to manage their heart dysfunction.
Customers who ingest too much of the medication may experience symptoms such as:
- Dizziness
- Blurred Vision
- Confusion
- Memory Loss
- Nausea
- Vomiting
- Loss of Appetite
- Tiredness
- Loss of Consciousness
Customers who ingest only half of their prescribed dose may experience a return of their heart symptoms, leading to symptoms such as:
- Tiredness
- Weakness
- Shortness of Breath
- Irregular Heartbeat
- Swelling
- Dizziness
- Chest Pain
If you believe that you have ingested the incorrect dosage of this medication, seek medical attention immediately.
Recall Lot Information
All consumers who use Digoxin should locate their medication bottle and compare their label with the chart below. If the Product Description, NDC number, Lot number, and Expiration Date match those below, you must take additional steps to ensure your health and safety.
Product Description |
NDC |
Lot Number |
Expiration Date |
| Digoxin 0.125 Tablet |
10135-0747-01 |
E3810 |
02/2025 |
| Digoxin 0.25mg Tablet |
10135-0748-01 |
E3811 |
02/2025 |
Have you found that your medication is part of the recall? Here’s what you should do:
Consumers
- Seek medical attention immediately if you believe you have taken an incorrect dosage of your medication.
- Call your doctor right away. Ask for a new prescription to replace your recalled medication and report any changes in your health.
- Monitor your health for any adverse symptoms and notify your physician if any concerns are noted.
- Consumers may contact Marlex Pharmaceuticals, Inc. at 1 (302) 328-3355. They are available Mon-Fri from 8:30 a.m. to 4:30 p.m. (EST).
- If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
Retailer
- Examine all inventory and remove stock affected by the recall immediately.
- Contact Marlex Pharmaceuticals, Inc. at 1 (302) 328-3355. Notify them of any recalled batches that have already been distributed to consumers.
- Notify affected consumers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
Wholesaler
- Examine all inventory and remove stock affected by the recall immediately.
- Contact Marlex Pharmaceuticals, Inc. at 1 (302) 328-3355. Notify them of any recalled batches that have already been shipped to retailers.
- Notify affected retailers of recalled batches that they have already or will receive.
- Contact MedWaste Management for information and assistance with disposing of the recalled medication.
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Tammy McKinney, RN, creator of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!
SOURCES:
www.FDA.gov
www.drugs.com