Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Actavis Inc. has made an agreement with the FDA not to issue any drugs from its Totowa facilities in Morristown, N.J., where Digitek is produced.

According to the Philadelphia Inquirer, the agreement says Actavis cannot resume its practices until it conforms to “the agency’s good manufacturing practice.” Actavis must improve its labs, facilities, and equipment.

Actavis has faced numerous lawsuits over the recalled drug Digitek. One such lawsuit includes the death of a patient and claims that Digitek is an unsafe and flawed drug.

Actavis would not comment if the FDA agreement had influenced the Digitek lawsuits or not.

According to reports filed to the FDA and consumers, the Center for Public Integrity has found that Digitek is responsible for 667 consumers’ deaths from April through June 2008. Pharma Live says health experts believe the FDA should have made more “aggressive warnings” to the public. The number of deaths associated with Digitek consumers have increased since the last reporting period.

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On October 8, John Dingell (D-MI), chairman of the U.S. House Committee on Energy and Commerce, and Bart Stupak (D-MI), chairman of that committee’s Subcommittee on Oversight and Investigations, wrote a letter to the U.S. Food and Drug Administration Commissioner Andrew C. von Eschenbach to request more information concerning the FDA’s procedure for examining manufacturing facilities of the generic drug manufacturer Actavis after several of the company’s products were recalled.

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Many previous Digitek consumers have steered away from Digitek after the recall. However, as Digitek has lost consumers, Lannett Company has only reaped the benefits.

Sales for Lannett’s digoxin, a generic form of Digitek, still have been strong since the recall of Digitek in April of this year.

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According to Huntington News, the United States Judicial Panel on Multidistrict Litigation (MDL) has ordered that all federal lawsuits about the double strength, defected Digitek be transferred to the U.S. District Court for the Southern District of West Virginia. This development in the lawsuit is taken as a result of the April 2008 recall on Digitek. Some tablets were twice as thick as usual, made with the double amount of medication.

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A generic form of digitalis - a heart drug - has been recalled in an unusual action that requires pharmacists to personally notify all customers who have purchased it.

Doctors prescribe the drug, Digitek, to treat heart failure and abnormal heart rhythms.

Actavis Totowa, a Totowa, N.J., manufacturer, recalled Digitek after consulting with the Food and Drug Administration. Actavis makes Digitek for Mylan Pharmaceuticals of Pittsburg, Pa.

Actavis counsel John LaRocca said the company recalled Digitek after at least one pill emerged from the manufacturing process at double the appropriate thickness. An FDA statement said: “These tablets may contain twice the approved level of active ingredient than is appropriate.”

Double-strength tablets could lead to toxic levels of digitalis in patients with renal failure.

“We had some concerns about the process,” LaRocca said. He said the company knew of no deaths linked to Digitek use but Actavis and the FDA had received 11 complaints about side effects since 2006.

Actavis has asked pharmacists to instruct consumers to return all unused Digitek pills and to consult their physicians. While recalls often result in the removal of drugs from pharmacy shelves, consumers seldom receive personal notification.

At North Shore Pharmacy in Huntington, supervising pharmacist Ron Wood said, “We never keep the generic [Digitek] in stock, so it [the recall] doesn’t apply.”

Joel Bassuk, pharmacist at Raindew Pharmacy in Manhasset, said he received the recall notice yesterday but he only has about five customers who use the drug.

“They said to immediately examine your inventory and discontinue all lots,” Bassuk said, noting he has had no reports of adverse side effects.

CVS spokesman Mike DeAngelis said the chain had removed all Digitek from its stores. “We went back to see which patients had prescriptions over the past 12 months and contacted them,” DeAngelis said.

SOURCE: Newsday

the following are answers to the most frequently asked questions (FAQ) regarding the Digitek recall

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.

What should I do if I was seriously injured as a result of Digitek?
You should contact contact an attorney to review your legal options as soon as possible. While product liability laws vary by state, you have a very limited time in which to file a claim against the manufacturer. If you have legal questions, you may contact Beasley Allen for a free legal consultation.

Please contact Wendi Lewis at 1-800-898-2034, extension 308. Or online at www.digitek-legal.com.

Representatives are available Monday through Friday, 8 am to 5 pm EST.

Q: How can I report serious side effects from, or reactions to, Digitek (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.

You may also report adverse side effects via the FDA’s online reporting form.

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.

the following is a timeline of events following Digitek from 1992 to its recall in April, 2008

February 1992 through September 2002, Charles Cullen, a former nurse and the most prolific serial killer in New Jersey history murders as many as 45 patients in 10 hospitals in New jersey and Pennsylvania. Digitek overdose was responsible for the cause of death in at least 17 patients^[1].

January through February 2006, a Food and Drug Administration (FDA) review of Actavis, finds potentially serious and unexpected adverse drug experiences” dating back to 1999 for several products, including Digitek (digoxin), that were not reported to the FDA.

On August 15, 2006, The Food and Drug Administration (FDA) notified the drug’s manufacturer, Actavis, in a warning letter dated August 15, 2006, of its failure to file periodic safety reports at its New Jersey facility. This failure violated Actavis’ adverse medical event reporting obligations, resulting in drugs being marketed without proper clearance and causing at least 26 adverse drug experiences.

On April 25, 2008, Actavis Totowa, LLC issued a Class I recall of Digitek (digoxin) tablets. Digitek was recalled due to the possibility that tablets were doubled in thickness and could contain twice the appropriate level of the active ingredient.

On May 1, 2008, a Newsday.com article, “Pharmacists will call you: Digitek recalled,” suggests that the defective Digitek tablets may have been sold for more than a year before the recall. Actavis counsel John LaRocca is quoted as saying that Actavis had some concerns about the process and recalled Digitek after at least one pill emerged from the manufacturing process at double the appropriate thickness

Do you have a Digitek claim?

If you or your loved one has suffered a serious injury or death as a result of Digitek, you may be entitled to compensation for medical expenses, loss of wages, and pain and suffering.

Please contact our Digitek lawyers today by filling out the brief questionnaire, or by calling our toll free number (1-800-898-2034) for a free, no-cost, no-obligation legal evaluation of your case.

on April 25, 2008, Digitek was recalled because of concerns that the medicine could contain twice the appropriate level

April 25, 2008, Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group, has initiated 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 Digitek recall was initiated it was learned that tablets contained twice the level of the active ingredient. Taking more than the safe level of Digitek can lead to Digitek toxicity.

Digitek recall information for patients

Patient inquiries related to the Digitek recall should be addressed to Stericycle customer service at 1-888-276-6166 with representatives available Monday through Friday, 8 am to 5 pm EST.

Digitek recall information for suppliers

Retailers who have this product are urged to return the product to their place of purchase.

Do you have a Digitek claim?

If you or your loved one has suffered a serious injury or death as a result of Digitek, you may be entitled to compensation for medical expenses, loss of wages, and pain and suffering.

Please contact our Digitek lawyers today by filling out the brief questionnaire, or by calling our toll free number (1-800-898-2034) for a free, no-cost, no-obligation legal evaluation of your case.

Beasley Allen law firm is actively pursuing Digitek recall and digitalis toxicity claims in all 50 states

Our defective drug and product liability lawyers work solely on behalf of individual plaintiffs that were injured by defective products, such as Digitek.

Over the past 29 years, we have successfully handled thousands of defective drug claims, having recovered more than $20 billion in verdicts and settlements for our clients.

Chad Cook is the Digitek lawyer investigating claims on behalf of the firm.

Do you have a Digitek claim?

If you or your loved one has suffered a serious injury or death as a result of Digitek, you may be entitled to compensation for medical expenses, loss of wages, and pain and suffering.

Please contact our Digitek lawyers today by filling out the brief questionnaire, or by calling our toll free number (1-800-898-2034) for a free, no-cost, no-obligation legal evaluation of your case.