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Digitek Tablets Recalled By Actavis Totowa

Apr 28, 2008 | Parker Waichman Alonso LLP

Actavis Totowa—the former Amide Pharmaceutical, Inc.—has just announced an “all-lots” recall of Bertek and UDL Laboratories Digitek (digoxin tablets, USP) as a precautionary measure.  It was discovered that that there was a possibility that tablets with twice the appropriate thickness might have been commercially released, meaning that these tablets may contain twice the approved level of active ingredient than is appropriate.   This recall is being conducted with the knowledge of the Food and Drug Administration (FDA).

Actavis Totowa, LLC is a United States manufacturing division of the international generic pharmaceutical company Actavis Group.  Actavis has initiated a Class 1 nationwide recall of Digitek (digoxin tablets, USP, all strengths) for oral use.  The medications are distributed by Mylan Pharmaceuticals, Inc. under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label.  Actavis manufactures the products for Mylan, which are distributed by Mylan and UDL under the Bertek and UDL labels; Bertek and UDL are affiliates of Mylan.  Class I recalls are conducted when dangerous or defective products that predictably could cause serious health problems or death are released.

The medication digitek is used to treat heart failure as well as abnormal heart rhythms.  A double-strength tablet poses a serious risk of digitalis toxicity in those patients suffering from renal failure.  Reduced kidney function will cause digitalis to accumulate in the body rather than being excreted normally through urine.  When this happens, any disorders that disrupt kidney functioning—including dehydration—make digitalis toxicity more likely.  Digitalis toxicity is a complication of digitalis therapy and may be caused by an acute ingestion of digitalis.  Digitalis toxicity can occur from a single exposure or chronic overmedication.

Digitalis toxicity can cause nausea, vomiting, diarrhea, dizziness, confusion, loss of appetite, low blood pressure, cardiac instability and irregular pulse, heart palpitations, and bradycardia.   Bradycardia is a slower than normal heartbeat rate.  Vision changes such as halos or light rings around objects, seeing lights and bright colors, experiencing changes in color perception, blind spots in vision, and blurred vision can also occur.  Patients can also experience decreased urine output and excessive nighttime urination, overall swelling, decreased consciousness, and difficulty breathing when lying down.  At its most severe, death can result from excessive Digitalis intake.  There have been several reports of illness and injuries related to the recalled medications.

Consumers can contact Stericycle’s customer service line at 1-888-276-6166.  Representatives are available Monday through Friday, 8:00 am to 5:00 pm eastern standard time.  Additional information about the voluntary recall can also be found at the Actavis Website at:  www.actavis.us.   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.