When it comes to heart failure medication, a labeling mix-up can have dire consequences.
That's why Marlex Pharmaceuticals of New Castle, Delaware, is recalling two lots of digoxin tablets at the 0.125-mg and 0.25-mg doses. The company is pulling the batches of the heart failure medication because certain bottles of 0.125-mg digoxin tablets are mislabeled with the 0.25-mg dose and vice versa.
The labeling snafu could cause either overdosing of underdosing in patients who unknowingly take the wrong strength of medication, Marlex warned in a notice posted on the FDA’s website.
Patients on 0.125-mg strength digoxin who take the higher dose could experience “significant drug toxicity” such as mental disorientation, dizziness, blurred vision, memory loss and fainting, the company added.
Meanwhile, patients who take a subpotent dose may experience loss of control of heart rate and potential heart failure exacerbation, Marlex said.
As of Thursday, Marlex said it hadn’t received any side effect reports linked to the recall.
The drug is used to treat mild to moderate heart failure. In kids, digoxin increases heart muscle contraction, while in adults, the medication is used to control ventricular response rate in patients with chronic atrial fibrillation.
The two lots were both set to expire in February 2025.
Labeling mix-ups have caused many recalls in the past.
In April 2022, for instance, Viatris pulled one lot of insulin glargine injection—the company's interchangeable biosimilar to Sanofi’s blockbuster diabetes med Lantus—because there was a chance the label could be missing on some vials.
Similar problems had cropped up in January of that year, when Viatris yanked one batch of non-interchangeable Semglee over fears of absent labels on certain prefilled pens.
More recently, Baxter Healthcare this week issued a recall for 13,502 vials of bendamustine HCl injection, which is used to treat cancers like lymphoma and chronic lymphocytic leukemia.
The drug was recalled after a customer complaint flagged issues with labels falling off the vials.