Here’s a news release from the U.S. Food and Drug Administration (FDA) regarding the recall of Digitek® (generic-digoxin):
Morristown, NJ--April 25, 2008--Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group, is initiating a Class I nationwide recall of Digitek® (digoxin tablets, USP, all strengths) for oral use. The products are distributed by Mylan Pharmaceuticals Inc., under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label.
The voluntary 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 approved level of active ingredient than it appropriate.
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. Death can also result from excessive Digitalis intake. Several reports of illnesses and injuries have been received.
Actavis manufactures the products for Mylan and the products are distributed by Mylan and UDL under the Bertek and UDL labels. Bertek and UDL are affiliates of Mylan.
Any customer inquiries related to this action should be addressed to Stericycle customer service at 1-888-276-6166; representatives are available Monday through Friday, 8 am to 5 pm EST.
If you or family members have experienced or reported a Digitek injury, you may be eligible for compensation or a lawsuit. Please contact Monheit Law for a free, no-obligation legal consultation.
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 healthcare providers.
This recall is being conducted with the knowledge of the Food and Drug Administration.
Any adverse reactions experienced with the use of this product, and/or quality problems should be reported to the FDA's MedWatch Program by calling 1-800-FDA-1088 or on the MedWatch website at www.fda.gov/medwatch. Please consult Monheit Law for your free, no-obligation legal consultation
Patients taking heart related drugs should not fear them for product negligence. Pharmaceutical companies have an ethical responsibility to provide patients and the medical community with a safe product.
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