Digitek Recall
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Digitek Recall
On April 25, 2008 Actavis Totowa - a United States manufacturing division of the international generic pharmaceutical company Actavis Group – initiated a nationwide recall of Digitek, their brand name for digoxin tablets. The recall was for all dosages of the product. In the United States the products are distributed by Mylan Pharmaceuticals Inc., under the "Bertek" label and by UDL Laboratories, Inc. under the "UDL" label. Both labels are affiliates of Mylan.
The "all lot" recall is due to the possibility that tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the level of digoxin than is reflected on the label. 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 an abnormally slow heart rate. According to the Actavis press release announcing the recall, "Death can also result from excessive Digitalis intake. Several reports of illnesses and injuries have been received."
Digitek is a form of digitalis, a chemical derived from the foxglove plant that has been used as a heart medicine since the 18th century. Several companies sell the medication generically as digoxin. It is the most popular choice among physicians for medicating heart arrhythmia and congestive heart failure.
Because of its widespread use and because cardiac problems are the most common life-threatening affliction among the U.S. population, Digitek is widely prescribed and it is believed that up to half the tablets in circulation at the time of the recall were double doses. Actavis notes that manufacture of the tablets is done in the United States and not offshore.
It is unclear at this point how many complaints the company and the FDA have received about this medication and how long the manufacturing error has been part of the production process. At the time of the recall, Actavis claimed that they had received only eleven complaints. However heart patients exhibiting symptoms such as those caused by digitalis toxicity may have been misdiagnosed prior to the recall, as the side effects of a Digitek overdose can be attributed to other causes.
