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Actavis Totowa LLC has recalled its heart drug, Digitek, which is used to treat heart failure and abnormal heart rhythms. The company says that some of the drugs distributed may have double the normal potency and could cause serious injury or death. But what is Digitek and what companies are involved in the recall?

What is Digitek?

Digitek is a form of digitalis – a chemical that comes from the foxglove plant that has been used in heart medications for centuries. It’s 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.

The drug can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, bradycardia (a resting heart rate of less than 60 beats per minute) and death. Several reports of illnesses and injuries have been received. According to various news reports, 11 people have reported becoming ill after using the drug.

What companies are involved?

There are primarily three companies involved with the recall – Actavis Totowa LLC, Mylan Laboratories and UDL Laboratories. However, deciphering how each is involved – not to mention who owns who – is a bit confusing. Here’s a brief description of each:

• Actavis Totowa LLC: Actavis Totowa LLC, based in New Jersey, is the U.S. division of the Actavis Group, an international generic drug maker based in Iceland. The company, which makes Digitek, operates in over 30 countries and employs over 10,000 people. It has approximately 600 generic products currently on the market and another 200 waiting approval. The company’s website is www.actavis.us/.
• Mylan Laboratories Inc.: Mylan Laboratories Inc., based in Pennsylvania, distributes Digitek under the label Bertek. It is the largest generic drug company in the United States. It has three subsidiaries – Mylan Pharmaceuticals, Mylan Technologies and UDL Laboratories. The company’s website is www.mylan.com/.
• UDL Laboratories Inc.: UDL Laboratories Inc. is based in Illinois and distributes Digitek under its own label. The company was purchased by Mylan Laboratories in 1996 and is the number one supplier of unit dose pharmaceuticals to hospitals. The company’s website is www.udllabs.com/.

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