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West Virginia - National Digitek Recall Attorneys
The Law Office of The Bell Law Firm, PLLC
Charleston Defective Drug Attorneys
& Medical Device Lawyers
Contact a West Virginia Digitek Recall Attorney online or call today - 1-866-912-3007 or 304-932-4225
The sad truth is giant pharmaceutical companies and a handful of medical device manufacturers have put the public at risk by bringing dangerous or defective products to market. Digitek, a drug used to treat heart failure and abnormal heart rhythms, may be putting the public at risk of several severe side effects.
If a dangerous drug or defective medical device has caused you serious injury, The Bell Law Firm, PLLC can explain your legal options and prepare your case for trial. Working with nationally recognized medical experts, engineers, and technicians, we work to establish fault on the part of manufacturers and demand financial compensation for our clients.
Digitek Recall - Digitek (digoxin tablets)-Class I Recall Because Tablets May Contain Twice The Approved Level Of Active Ingredient
Actavis Totowa LLC notified healthcare professionals of a Class I nationwide recall of all strengths of Digitek, a drug used to treat heart failure and abnormal heart rhythms. The products are distributed by Mylan Pharmaceuticals Inc., under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label. The product is being recalled due to the possibility that tablets with double the appropriate thickness may contain twice the approved level of active ingredient. The existence of double strength tablets poses a risk of digitalis toxicity in patents with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Several reports of illnesses and injuries have been reported. Patients should contact their healthcare professional with questions.
Read the entire 2008 MedWatch Safety Summary, including a link to the manufacturer's press release regarding this issue at:
Patients using Digitek who have medical questions should contact their health-care providers.
What Is Digitek and who's Involved?
Actavis Totowa LLC has recalled its heart drug, Digitek, which is used to treat heart failure and abnormal heart rhythms. Actavis Totowa LLC says that some of the drugs distributed may have double the normal potency and could cause serious injury or death. If you or a loved one has taken Digitek please contact you doctor immediately, if you or a loved one has been harmed by this drug contact our law firm for a free consultation @ 1-866-912-3007 or 304-932-4225.
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 double strength tablets pose a risk of digitalis toxicity in patients with renal failure and cause the following symptoms:
- Nausea
- Vomiting
- Dizziness
- Low Blood Pressure
- Cardiac Instability
- Bradycardia
- Death
What companies are involved?
There are primarily three companies involved with the recall - Actavis Totowa LLC, Mylan Laboratories and UDL Laboratories.
- 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.
- 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.
- 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.
What is also important to know is the FDA (U.S. Food and Drug Administration) BLASTED the manufacturer Actavis Totowa LLC for it's safety and reporting violations. This may have prompted the company to recall the drug Digitek after realizing several lots have been shipped that may have contained double the normal potency which could lead to serious injury or death.
The FDA letter included the following violations to Actavis from an inspection done to their New Jersey plant in 2006:
- Six potentially serious and unexpected adverse drug events dating back to 1999 for products such as Digoxin [Digitek] ... that were not reported to the FDA.
- Two cases where the patients' adverse experiences had not [been] resolved when your firm received the initial reports, and in one case where only minimal case information concerning a fatal adverse event had been initially reported to your firm, there were no follow-up investigations.
- Data received from ... spontaneous reports or clinical trials were not reviewed for seriousness and expectedness.
- The inspection found that your firm is not following procedures that were established for filing periodic safety reports. This failure to submit periodic safety reports has resulted in at least 26 ADEs [Adverse Drug Experiences] which were never reported to the FDA.
- Your firm lacks procedures regarding follow-up investigations, adequate completion of the MedWatch form, maintenance of records to assure timely submission of ... reports and evaluation of adverse event data for serious outcome of event expectedness.
If you've been injured by a drug, contact an attorney whose practice focuses in this area of the law. Consultations are free, without obligation and strictly confidential. To contact a qualified attorney to discuss your situation, please contact our law firm for a free consultation of your Digitek injuries @ 1-866-912-3007 or 304-932-4225 we may be able to help.
Do I Have a Lawsuit?
If you or a loved one has used Digitek and suffered in any way, you should contact us immediately. You may be entitled to compensation for your injuries and we can help. Contact Defective Drug & Medical Device Attorneys that will fight these mega-pharmaceutical companies to protect your rights.
As your legal representation, The Bell Law Firm, PLLC develops and presents evidence linking your injuries to the use of a particular medical product. Given the fact that recalls have already occurred in the case of many of these products, facts already exist in evidence regarding their dangers. In order to counter defense arguments claiming injuries were caused by a pre-existing condition or factors unrelated to their product, our personal injury attorneys consult with medical doctors and medical device experts, submitting evidence and proof in support of your case.
Unsure if you have a Case? Contact The Bell Law Firm, PLLC Today
Dangerous drug and defective medical device cases can be complicated. If you're not sure whether you have a reason to file a lawsuit, contact Charleston defective drug attorneys and medical device recall lawyers at The Bell Law Firm, PLLC. We provide free consultations and will evaluate the facts of your case to determine the legal options available to you.
