Actavis Totowa, LLC has recalled all lots of its heart drug, Digitek. The company says that some tablets may contain double the amount of medication which could lead to serious injury or death. The Class I recall is being coordinated with the U.S. Food and Drug Administration (FDA).
Details of the Digitek recall
According to the FDA and the company’s website, www.actavis.us/:
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 (a resting heart rate of less than 60 beats per minute). Death can also result from excessive Digitalis intake. Several reports of illnesses and injuries have been received.
This is a Class I recall, the most serious type, meaning that serious injury or death may occur.
Manufacturer / Distributor
The drug is manufactured and distributed by several different companies.
- Manufacturer: The actual manufacturer of Digitek is Actavis Totowa LLC, which is the U.S. division of the Actavis Group – an international pharmaceutical company based in Iceland. The products are marketed under the name Digitek and digoxin tablets, USP, all strengths for oral use.
- Distributors: The products are distributed by Mylan Pharmaceuticals, Inc. under a Bertek label and UDL Laboratories, Inc. under a UDL label.
Additional consumer / retailer information
Any customer inquiries related to this action should be addressed to Stericycle customer service at 1-888-276-6166 with representatives available Monday through Friday, 8 am to 5 pm EST. Retailers who have this product are urged to return the product to their place of purchase. If consumers have medical questions, they should contact their health care providers.
Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088, by Fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at www.fda.gov/medwatch.
