People are receiving phone calls and pharmacy letters notifying them that their heart drug may be unsafe.
Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group, is initiating a nationwide recall of Digitek (digoxin tablets, all strengths) for oral use. The products are distributed by Mylan Pharmaceuticals Inc., under a “Bertek” label and by UDL Laboratories, Inc. under a “UDL” label. All lots of the drug Digitek, a generic form of digoxin, are being removed from shelves.
The voluntary recall is due to the possibility that tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredients than is appropriate.
Digitek is used to treat heart failure and abnormal heart rhythms. The existence of double strength tablets poses a risk of digitalis toxicity in patients with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Death can also result from excessive digitalis intake. Several reports of illnesses and injuries have been received.
Actavis manufactures the products for Mylan and the products are distributed by Mylan and UDL under the Bertek and UDL labels. Bertek and UDL are affiliates of Mylan.
This recall is being conducted with the knowledge of the Food and Drug Administration. Given the risk of serious injury or death associated with the use of the recalled drug, pharmacists have been asked to directly contact customers. Many pharmacies are reaching out to any individual who had a prescription filled within the past 12 months.