Heart Drug Recall Issued Due to Labeling Error, FDA Alerts Public
Generally, when collecting your prescribed medication, you rely on clear guidelines provided by your pharmacist and have faith in your doctor’s dosage advice. Nonetheless, errors can occur, as demonstrated by the recent FDA announcement about a critical recall involving heart medication caused by a labeling mistake that affects the dosage. Keep reading to discover why you might need to discontinue using particular tablets at once.
In a press statement dated August 31, the FDA disclosed that Marlex Pharmaceuticals has opted to recall a specific lot of Digoxin Tablets in both 0.125-milligram and 0.25-milligram dosages. The drug is administered across the U.S. and aims to manage mild to moderate cases of heart failure. In addition to enhancing heart muscle contractions in young patients, the drug is also used to regulate the ventricular response in adult patients with chronic atrial fibrillation, or AFib.
Dosage Confusion Due to Incorrect Labeling
The FDA’s report highlighted that the labels on the recalled medication lots are incorrect. Specifically, the package designated for 0.125-milligram tablets actually contains 0.25-milligram tablets, and vice versa. The FDA notes that this could result in either underdosing or overdosing for patients who take the medication without being aware of the label error.
Taking an excessive amount of the drug meant for the lower dose can lead to severe side effects such as mental confusion, dizziness, visual disturbances, memory gaps, and fainting. Conversely, those who ingest a lower dosage than intended may suffer from ineffective heart rate control, which could potentially escalate to heart failure.
Immediate Action Recommended
While Marlex Pharmaceuticals has yet to document any detrimental incidents stemming from this recall as of August 31, the FDA strongly advises those with these tablets to halt their use and return them to the purchase location. Marlex is also reaching out to distributors and consumers through email to coordinate the return of the affected medications.
To identify the affected tablets, you can observe the tablet’s color. The 0.125-milligram tablets are yellow and have “N” and “201” inscribed on one side, whereas the 0.25-milligram tablets are white to off-white with “N” and “202” on one side. Both affected medications have an expiration date of February 2025 and come in packs of 100, with distinct lot numbers of E3810 and E3811, respectively.
Seek Medical Guidance if Necessary
If you’re taking this medication and have experienced any issues or adverse reactions, the FDA advises immediate consultation with a healthcare provider and reporting through the MedWatch Adverse Event Reporting program.
Types of Damages and Potential Compensation in a Heart Medication Recall Lawsuit
When a medication recall occurs, especially one that involves heart medication, the stakes are incredibly high. Patients who have been adversely affected by the recalled medication may have legal recourse to seek damages for their injuries and other losses. Here are the types of damages that could be awarded in a product liability lawsuit concerning a medication recall like this one.
- Medical Expenses – The most immediate form of relief that victims may be entitled to is for medical expenses incurred due to the flawed medication. These costs can include hospital stays, diagnostic tests, and treatment for conditions or symptoms triggered by the wrong dose.
- Pain and Suffering – Compensation for pain and suffering can cover both physical pain and emotional distress. Given that the medication is for heart conditions, any mistake could lead to significant health risks, affecting both the patient’s physical well-being and emotional state.
- Loss of Earnings – If the medication error has led to a temporary or permanent inability to work, compensation may be awarded for loss of earnings. This could also include future earnings if the plaintiff is no longer able to work in the same capacity as they could before.
- Wrongful Death – In the most tragic circumstances, where the medication error leads to the death of a patient, the family of the deceased can file a wrongful death claim. They could seek compensation for funeral expenses, loss of financial support, and the emotional trauma of losing a loved one.
- Punitive Damages – In cases where the error was due to gross negligence or intentional misconduct on the part of the pharmaceutical company, punitive damages might be awarded. These are designed to punish the wrongdoer and deter similar behavior in the future.
- Legal Costs – Plaintiffs may also seek compensation for legal expenses incurred during the lawsuit, especially if they win the case. These can include attorney fees, court costs, and the costs of expert witnesses.
Anyone who has been affected by a medication recall should consult with one of our experienced attorneys to discuss their specific circumstances and potential legal remedies.
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Parker Waichman LLP helps families recover monetary compensation for harm caused by dangerous products like this defective product. For your free consultation, contact our national product liability law firm today by using our live chat or calling 1-800-YOUR-LAWYER (1-800-968-7529).
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