On April 25, Actavis Totowa LLC initiated a Class 1 nationwide recall of Digitek® (digoxin tablets, USP, all strengths) for oral use. The products, manufactured by Actavis, are distributed by Mylan Pharmaceuticals, Inc. under the "Bertek" label and by UDL Laboratories, Inc. under the "UDL" label.

Press release from April 25

Acting together with Actavis to enact the recall of the product, Mylan Pharmaceuticals, Inc. as the distributor of Digitek, retained Stericycle customer service center (tel. 1-888-276-6166) to act as the recall coordinator immediately following Actavis’ decision to recall the product.

Please direct all inquiries you may have regarding this recall to Stericycle for proper handling and distribution.

Representatives at the service center are available to support all consumer queries and to provide direction on how to return your product.

If you have any questions about your treatment, or any medical inquiries regarding the product or possible substitutes, you should contact your physician immediately.

Frequently asked questions:

• Q: Why is Actavis recalling Digitek® (digoxin)?
  A: This voluntary all-lot recall is due to the possibility that some tablets with double the appropriate thickness may have been commercially released. These tablets may contain twice the approved level of active ingredient than is appropriate.
  
  
• Q: What should I do if I’m taking Digitek® (digoxin)?
  A: Patients should contact their physician to get a new prescription. All inquiries related to returning your product or the recall should be addressed to Stericycle customer service at 1-888-276-6166 (option 1 for consumers or option 2 for wholesalers/distributors and retailers.
  Representatives are available Monday through Friday, 8 am to 5 pm EST.
  
  
• Q: How can I report serious side effects from, or reactions to, digoxin?
  A: If you wish to report an adverse experience from taking digoxin, you are directed to select option “3” from the menu provided on the Stericycle answering service where you will be directed to an Actavis representative who will process your information.
  We also report such incidences to the FDA in accordance with Federal Regulations. Please call customer service at 1-888-276-6166, extension 3.
  Representatives are available Monday through Friday, 8 am to 5 pm EST.
  If you need medical attention or have any inquiries regarding your treatment, however, you should contact your physician.
  
  
• Q: What is Digitek® (digoxin)?
  A: Digitek is the brand name for digoxin tablets, USP 0.125 mg and 0.25 mg, manufactured by Actavis and distributed by Mylan Pharmaceuticals, Inc. under the Bertek and UDL labels. It is prescribed for oral use to treat heart failure and abnormal heart rhythms.
  
  
• Q: Where is Digitek® (digoxin) manufactured?
  A: Digitek is manufactured in the United States by Actavis Totowa, in New Jersey.
  
  
• Q: Is the recall just in the United States, or also in other countries?
  A: The recall is only in the United States.