DigitekRecall.org

Digitek Recall Blamed on Shoddy Manufacturing

Administrator — Sun, 08 Jun 2008 15:36:09 +0000

A Digitek class action lawsuit filed on the heels of April’s Digitek recall raises serious questions about the way the defective pills were made. According to the Digitek class action lawsuit, a US plant that made some of the defective Digitek tablets was the subject of a Food & Drug Administration (FDA) warning letter in 2006.

The Digitek class action lawsuit, filed in US District Court in New Jersey, says that the FDA issued a warning letter to Actavis back in August 2006 for failing to provide periodic safety reports at its oral dose manufacturing plant in Little Falls, N.J. According to the complaint, some of the faulty Digitek came out of that plant. The Digitek lawsuit also claims that another FDA inspection in early 2006 revealed six potentially serious and unexpected adverse drug events dating back to 1999 for products that included generic Digitek, that weren’t reported to the agency. READ MORE

Digitek: Little Room for Error

Administrator — Sun, 08 Jun 2008 15:34:28 +0000

Charleston, WV: Elizabeth J. Starr was prescribed Digitek (digoxin) tablets for a heart condition and was taking her medication diligently. What she didn’t know, however, was that the recalled tablets she was taking contained a double dose of digoxin, and she died May 5th. A lawsuit has been filed on behalf of her estate; one of many coming out of the woodwork after a manufacturing defect resulted in twice the levels of digoxin, as recommended.

Digoxin helps to strengthen the heart and is commonly prescribed for a host of heart conditions including atrial fibrillation, atrial flutter and heart failure. Digoxin helps the heart along in the beat department, and contributes to a more efficient contraction of the heart muscle. READ MORE

LAMB FIRM INVESTIGATES INJURIES ASSOCIATED WITH DIGITEK® HEART MEDICATION

Administrator — Mon, 19 May 2008 02:21:25 +0000

Nationally Recognized Healthcare Attorney Archie Lamb Establishes Digitek® Database

Friday May 16, 2008: Birmingham, Alabama: Healthcare attorney Archie Lamb of the Lamb Firm, LLC in Birmingham, Alabama announced an investigation of injuries and the facts surrounding the recall of the heart medication DIGITEK®. The nationally distributed drug was manufactured by Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group.
The company initiated a Class 1 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.
“Our initial investigation indicates that many people have suffered injuries associated with this drug” noted Lamb. “We anticipate litigation on behalf of many of the injured individuals based on the results of our on-going investigation. Unfortunately, our database of injured individuals continues to grow” he concluded.
Additional background information is available from the Contacts noted above and at www.ditigekrecall.org.

Patients Sue Icelandic Drugmaker Over Recalled Heart Drug

Administrator — Mon, 19 May 2008 01:51:23 +0000

WallStreetJournal.com

Out goes the drug, in come the lawsuits.

On April 25, Icelandic generic drug maker Actavis recalled its heart drug Digitek, or digoxin, over concerns that some batches of the medicine may have contained tablets that were twice the normal thickness and strength.

Today, two weeks since the recall, a lawsuit seeking class action status was filed against privately-held Actavis, as well as Mylan and its UDL Laboratories unit, which distributed the meds. Plaintiffs are seeking damages over alleged injuries and to cover medical monitoring in case of future health trouble. READ MORE

Generic heart drug Digitek recalled by Icelandic maker

Administrator — Mon, 19 May 2008 01:47:57 +0000

By Catherine Larkin/Bloomberg News

Actavis Group has recalled all lots of the generic heart drug Digitek because they may contain twice as much medicine as they should.

“Several reports of illnesses and injuries have been received” in connection with the tablets, distributed by Mylan Laboratories Inc. under its Bertek and UDL brands, according to a notice posted Monday on the Food and Drug Administration’s Web site. Actavis has received 11 reports of side effects in about a year, though some may be unrelated to this issue, said John LaRocca, the firm’s general counsel.

Digitek is a form of digitalis, a chemical derived from the foxglove plant that has been used as a heart medicine since the 18th century. The medication is sold generically as digoxin by several companies and is prescribed to treat heart failure and abnormal heart rhythms. Excess dosing in patients with kidney failure may cause nausea, vomiting, dizziness, low blood pressure, slow heartbeat or death, the FDA said. READ MORE

Actavis Totowa (formerly known as Amide Pharmaceutical, Inc.) recalls all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP) as a precaution

Administrator — Fri, 16 May 2008 16:55:13 +0000

Morristown, NJ, 25 April, 2008 – Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group, is initiating a Class 1 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 is 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 illness 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 with representatives available Monday through Friday, 8 am to 5 pm EST. Additional information about the voluntary recall can also be found 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. 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 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. Media contact:Hjordis ArnadottirDirector, External CommunicationsEmail: harnadottir@actavis.comTel.: +1 (973) 889-6686

Actavis Division Recalling Heart Treatment

Administrator — Fri, 16 May 2008 16:54:00 +0000

Actavis Totowa, a U.S. manufacturing division of Icelandic drugmaker Actavis, has recalled all lots of heart failure treatment Digitek as a precautionary measure.

The company announced the Class I nationwide Digitek (digoxin tablets) recall after the possible commercial release of tablets with twice the approved level of the active ingredient, posing a risk of digitalis toxicity in patients with renal failure. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, bradycardia and death. Several reports of illness and injury have been received, the FDA said.

Digitek is distributed by Mylan affiliates Bertek and UDL under their respective labels.