On April 25, 2008, Actavis Totowa, LLC, a United State manufacturing division of the international generic pharmaceutical company Actavis Group initiated a Class 1 nationwide recall of its Digitek® product (Digoxin tablets USP, all strengths) for oral use (See Activis Press Release). The Digitek products were distributed under a “UDL” label by UDL Laboratories, Inc., and also under a “Bertek” label by Mylan Pharmaceuticals.
Our law firm is handling Digitek (digoxin) recall cases in all 50 states. If you or a loved one have experienced an adverse event related to Digitek, you should contact us immediately. You may be entitled to compensation for your injuries and we can help.
All lots of the Digitek product were recalled due to the possibility that tablets with “double” the appropriate thickness were commercially released. This extra thickness in the tablets may cause the product to have twice the approved level of active ingredient than is appropriate.
The Digitek® product is used by physicians to treat heart failure and abnormal heart rhythms in patients.
If patients receive too much Digitek®, such as a double strength dose, then there is a risk of digitalis toxicity. The potential signs and symptoms of digitalis toxicity can be nausea, vomiting, low blood pressure, dizziness, cardiac instability and bradycardia. Death can also result from too much Digitek®. To date, there have been reports of illness and injury in association with the use of Digitek®.
Any adverse reactions experienced with the use of Digitek® can and should be reported to the FDA’s Medwatch Program by phone at (800) FDA-1088, or by fax at (800) FDA-0178, or by mail at Medwatch, FDA, 5600 Fishers Lane, Room 12B05, Rockville, MD 20857 or on the FDA’s Medwatch website at www.fda.gov/medwatch.
Additionally, Actavis has stated that any customer inquiries related to the Digitek® recall should be addressed to Stericycle Customer Service at (888) 276-6166. Representatives are available Monday through Friday, 8:00 a.m. to 5:00 p.m. (EST) to take calls.
Any additional information about this Digitek® recall may be found at www.actavis.us.
This recall is being conducted with the knowledge of the FDA. The FDA’s Digitek® recall notice can be found at http://www.fda.gov/oc/po/firmrecalls/actavis04_08.html. (See FDA Digitek® Recall Notice).
More recently on May 16, 2008, the FDA issued a CVM update with regarding to the Digitek® product (See FDA CVM May 16, 2008). This notification indicated that Veterinarians who use the human drug Digitek® (Digoxin tablets, USP) to treat their patients should also be aware of the possibility that the tablet strength may be double for Digitek®. This increase in tablet active ingredient could result in life-threatening adverse drug reactions in animals.
Frequently Asked Questions about Digitek®
Some of the Frequently Asked Questions about Digitek® are provide below with answers. However, additional information can be found on the Actavis website.
If you have any questions, concerns or experience any symptoms of Digitalis, you should not hesitate to contact your physician immediately.
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.
In May 2008, pharmacies began sending out letters to patients taking the recalled Digitek product providing information with regard to the Urgent Drug Recall. These pharmacy letters to patients provide information to the patients about who is instituting the Digitek recall and provide explanations as to why the product is being recalled. In the Wal-Mart Pharmacy recall letter, the patient is told:
“The Digitek voluntary recall is due to the possibility that tablets with double the appropriate thickness may have been commercially released. The tablets may contain twice the approved level of the active ingredient than is appropriate.”
The letter further discusses the potential risk of digitalis and the possible symptoms of digitalis toxicity.
The pharmacy letter concludes by stating…
“If you are currently taking Digitek 0.125 mg or 0.25 mg tablets, or have a supply on hand, you should contact Stericycle Customer Service at (888) 276-6166. Representatives will be available Monday through Friday, 8:00 am to 5 pm EST.
(See Wal-Mart Pharmacy Letter on Digitek Recall)
To date, no additional information about the recall has been provided by Actavis The company has not indicated how many lots of double the strength tablets were manufactured an/or shipped out commercially. Additionally, no information has been provided about how long the problems with the Digitek tablets has been going on or when the manufacturing problem was discovered. It is believe the FDA will have conducted a Form 483 inspection of Actavis’ manufacturing facility for Digitek and that report may shed some light on these questions. For now, the FDA report is not available on the FDA’s website.
Do I Have a Digitek Lawsuit?
Our law firm is handling Digitek (digoxin) recall cases in all 50 states. If you or a loved one have experienced an adverse event related to Digitek, you should contact us immediately. Yiou may be entitled to compensation for your injuries and we can help.
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