Colorado Law Blog

Actavis Totowa Recalls all Drug Products from Little Falls Plant

4 Aug, 2008 No Comment

Actavis Totowa Announces Voluntary Recall at the Retail Level of All Drug Products Manufactured at its Little Falls, New Jersey Facility

FOR IMMEDIATE RELEASE — Morristown, NJ, August 1, 2008 — Actavis Totowa LLC, a generic drug manufacturer, is announcing a voluntary recall, to the retail level, of all drug products manufactured at its Little Falls, New Jersey facility. This is a precautionary, voluntary action by Actavis following an inspection conducted by the Food and Drug Administration earlier this year.

The inspection at Little Falls revealed operations which did not meet the FDA’s or Actavis’ standards for good manufacturing practices. Actavis Totowa is voluntarily recalling these products from the pharmacy/retail level, which includes wholesalers and hospitals. The company has informed the FDA regarding this action.

Actavis Totowa, LLC is a United States subsidiary of Actavis Group hf. This voluntary action is limited only to the Actavis Totowa products manufactured in the Little Falls, NJ facility listed below. Products manufactured by Actavis Elizabeth LLC, Actavis South Atlantic LLC, Actavis Mid Atlantic LLC or Actavis products manufactured in other facilities are thus not impacted by this recall

Amantadine 100mg capsules	Meperidine & Promethazine capsules
Amibid DM ER tablets	Meperidine HCl 100 mg and 50 mg tablets
Amibid DM tablets	Methenamine Mandelate 0.5 g and 1.0 g tablets
Amidrine capsules	Mirtazapine 15 mg, 30 mg, and 45 mg tablets
Amigesic 500 mg caplets and 750 mg caplets	Mirtazapine OD tablets, 15 mg, 30 mg and 45 mg
Amitex PSE tablets	Multi-ret Folic 500 mg tablets
Bellamine S tablets	Multi-vita-bets 0.5 mg and 1.0 mg FL & FE tablets
Betaxolol 10 mg and 20 mg tablets USP	Multi-vita-bets 0.25 mg, 0.5 mg and 1 mg FL tablets
Buspirone HCL 5 mg, 10 mg, 15 mg and 30mg tablets	Naltrexone 50mg tablets
Carisoprodol & Aspirin tablets	Oxycodone & Acetaminophen 5/500mg capsules
Carisoprodol, Aspirin & Codeine tablets	Oxycodone HCl 5 mg, 15 mg and 30 mg tablets
Carisoprodol 350mg tablets	Oxycodone HCl 5 mg capsules
Chlordiazepoxide w/ Clidinium Bromide capsules	Pentazocine & Acetaminophen tablets
Chlorzoxazone 250mg	Pentazocine & Naloxone tablets
Cilostazol tablets 100mg	Phenazopyridine HCl 100 mg and 200 mg tablets
Choline Magnesium Trisalicylate 500 mg, 750 mg and 1000 mg tablets	Phendimetrazine Tartrate 35mg tablets
Cyclobenzaprine HCL 5 mg and 10 mg	Phentermine HCl 37.5 mg tablets
Dexchlorpheniramine Maleate 4 mg and 6 mg tablets	Phentermine HCl 15 mg, 30 mg and 37.5 mg capsules
Dipyridamole 25 mg, 50mg, and 75 mg tablets	Prenatal Formula 3 tablets
Glyburide 1.5 mg, 3.0 mg and 6.0 mg tablets	Prenatal Plus 27 mg FE tablets
Guaifenesin & Codeine Phosphate tablets	Prenatal Rx tablets
Guaifenesin & Phenylephrine tablets	Quinaretic 10mg/12.5mg, 20 mg/12.5 mg and 20 mg/25 mg tablets
Guanfacine 1.0 mg and 2.0 mg HCl tablets	Rifampin 300mg capsules
Hydrocodone & Homatropine tablets	Sodium FL 0.5 mg and 1.0 mg tablets
Hydromorphone HCl tablets	Tizanidine HCl 2 mg and 4 mg tablets
Hydroxyzine 10 mg, 25 mg and 50 mg tablets	Trimethobenzamide 300mg capsules
Hyoscyamine Sulfate 0.125 mg SL	Trimipramine Maleate 25mg, 50mg, 100mg capsules
Hyoscyamine Sulfate 0.375mg SR tablets	Trivita 1 mg FL tablets
Hyoscyamine Sulfate 0.125 mg (oral) tablets	Ursodiol capsules, 300mg
Isradipine 2.5 mg and 5 mg capsules	Vitacon Forte capsules
Loxapine 5 mg, 10 mg, 25 mg, and 50 mg capsules	Vitaplex Plus tablets
Meclizine Chewable 25 mg tablets	Vitaplex tablets (FC)
Meloxicam 7.5 mg and 15 mg tablets	Yohimbine HCl 5.4 mg tablets

Denver Digitek Death Lawsuit Filed by Digitek Lawyers Klein | Frank, P.C

4 Aug, 2008 No Comment

Digitek Death Lawsuit - Actavis Totowa Accused of Producing Dangerously Defective Digitek Heart Pills in Lawsuit Filed by Klein | Frank, P.C.

Denver, Colorado, August 1, 2008. A lawsuit filed in United States District Court in Denver, Colorado on August 1, 2008 charges pharmaceutical company Actavis Totowa LLC with manufacturing and distributing defective Digitek
heart drug pills that contained dangerously excessive doses of the drug’s active ingredient, digoxin, causing life-threatening adverse drug reactions.

Digitek is typically prescribed to treat irregular heartbeat or heart failure. The Federal suit, filed in the wake of an FDA Digitek recall, alleges defective Digitek contained amounts of digoxin exceeding the dose set forth on the label and in some cases exceeding the dose approved for medical treatment in humans.

The litigation, brought by a Denver woman on behalf of her deceased husband, alleges defective Digitek pills containing a lethal dose of the active ingredient caused the death of her husband.

The death occurred in August 2007 over a year after FDA inspections of the manufacturing operations of Actavis Totowa, LLC revealed the manufacturers failure to comply with federal regulations to ensure the safety of its medications.

The FDA issued a Revised Warning Letter to Actavis Totowa, LLC on February 1, 2007 finding that the inspection of the company’s 101 East Main Street, Little Falls, New Jersey facility that took place July 10, 2006 through August 10, 2006 revealed that drug products manufactured at that facility were adulterated under the meaning of the Federal Food,
Drug and Cosmetic Act.

A year later on April 25, 2008 the FDA announced a nationwide recall of all Digitek tablets because of the potential that the tablets were double the appropriate thickness and contained up to twice the approved level of the active ingredient. The suit claims the victim was prescribed Digitek and innocently ingested defective tablets that contained lethal levels of the active ingredient.

The suit blames Actavis for failing to heed FDA warnings in July and August of 2006 and February of 2007, that many of the drug products that were produced, manufactured and released to the public by Actavis were adulterated and as a result the drugs were not safe for patients to ingest.

“What makes this so tragic is that Actavis chose not to take appropriate measures in response to the FDA warnings in 2006 and 2007. Scores of people have unnecessarily lost their lives,” said Beth Klein, pharmaceutical litigation attorney with the law firm Klein | Frank, P.C. in Denver, Colorado. Klein and Carrie Frank
of Klein | Frank, P.C. are representing the family of the deceased.

The suit charges the drug maker knew or should have known about the manufacturing and production defects and that the recalled Digitek was adulterated, misbranded, defective, unreasonably dangerous and unfit for its intended uses. “Despite the undeniable knowledge, Actavis placed tens of thousands of patients, including our client, unnecessarily at risk of catastrophic injury and death,” said Klein.

Klein | Frank, P.C. is recognized nationally for its practice in mass torts litigation, multidistrict litigation and complex litigation including class actions, serious personal injuries, wrongful death, products liability, defective medical devices and pharmaceuticals. For assistance with any questions concerning digitek or this recall, call our digitek lawyers at 303-448-8884.

Digitek Digoxin Lawyers, Litigation and Frequent Questions

9 Jul, 2008 No Comment

The manufacturer, Actavis Totowa, LLC has issued a press statement that responds, in part to frequently asked questions about the Digitek recall and the specific Digitek tablets that are at issue. Check your prescription for digoxin tablets manufactured by Actavis. The defective digoxin or Digitek products were distributed by:

Mylan Pharmaceuticals, Inc. under the “Bertek” label

UDL Laboratories, Inc. under the “UDL” label.

OUr recommendation is that you or your representative visit your pharmacist as soon as possible to determine the manufacturer and distributer of the Digitek that you have taken. Many pharmacies do not keep this information for over two years. If you are concerned, contact us, and we will assist you in securing evidence.

We are aware that many individuals are being solicited to return their pills to the manufacturer or distributer, and that the manufacturer of Digitek is requesting that you contact them on their website. The pills are evidence for any claim that you might have. We urge our client to keep their pills in a secure location. Be sure to keep them separated from your medications that you take. Further, keep all prescriptions, bottles, and receipts as best as possible for any potential Digoxin lawsuit.

If you have any further questions, please contact Carrie Frank at 303-448-8884. She will be happy to help you on Digitek/Digoxin recall lawsuit questions.

The following is the information from Actavis Totowa from its recall website:

Digitek® recall – customer support and frequently asked questions

On April 25, Actavis Totowa LLC initiated a Class 1 nationwide recall of Digitek® (digoxin tablets, USP, all strengths) for oral use. The products, manufactured by Actavis, are distributed by Mylan Pharmaceuticals, Inc. under the “Bertek” label and by UDL Laboratories, Inc. under the “UDL” label.

Acting together with Actavis to enact the recall of the product, Mylan Pharmaceuticals, Inc. as the distributor of Digitek, retained Stericycle customer service center (tel. 1-888-276-6166) to act as the recall coordinator immediately following Actavis’ decision to recall the product.

Please direct all inquiries you may have regarding this recall to Stericycle for proper handling and distribution.

Representatives at the service center are available to support all consumer queries and to provide direction on how to return your product.

If you have any questions about your treatment, or any medical inquiries regarding the product or possible substitutes, you should contact your physician immediately.

Frequently asked questions:

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 * (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 * , 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.

Check your car seats for a Happy Father’s Day!

14 Jun, 2008 No Comment

If you have clients, friends, family with little kids urge them to have Safe Kids USA do a car seat check. It take only a few minutes to keep our kids (and grandkids) safe for next Fathers Day.

You do everything you can to keep you kids safe, right? But, do you know for sure if your kids’ car seats are installed properly? Did you know that 4 out of 5 car seats are actually not installed right and those the kids are not as safe as they could be?

Watch a Safe Kids video, narrated by a dad whose kids narrowly escaped serious injury when the family car flipped over several times

http://sk.convio.net/site/R?i=ZNP7yV0BnniXU7-vwfYMoQ..

Find a Carseat Check Up Event Near You

http://sk.convio.net/site/R?i=mzlTO_QgLV_KiDzuMJaJwg..

Find a Safe Kids Coalition Near You

http://sk.convio.net/site/R?i=x_DMdKKDeZDNONisB6MAlQ..

More Defective Toy Recalls - Lead Paint

30 May, 2008 No Comment

Despite all of the publicity surrounding lead paint, more recalls have been issued for defective kids products:

http://www.cpsc.gov/cpscpub/prerel/prhtml08/08278.html Pirates of the Caribbean sleeping bag

http://www.cpsc.gov/cpscpub/prerel/prhtml08/08280.html Shaker Guiro Instrument

http://www.cpsc.gov/cpscpub/prerel/prhtml08/08282.html Tinker Bell Wands

http://www.cpsc.gov/cpscpub/prerel/prhtml08/08283.html Sure Grip Paint Brushes

http://www.cpsc.gov/cpscpub/prerel/prhtml08/08285.html Floppy Friends Horse Toys

Gadolinium Deadlines for Lawsuits and Legal Rights

29 May, 2008 No Comment

The first layer of statutes of limitations for certain gadolinium cases runs on June 6, 2008. After this deadline, some cases may be time barred, and some individuals may forfeit their legal rights. It is critical that you do not delay and that you contact a lawyer as quickly as possible.

If you think that you may have been harmed by Magnevist (gadopentetate dimeglumine), Ominiscan (gadodiamide); OptiMARK (gadoversetamide); MultiHance; (gadobenate dimeglumine); or Prohance (gadoteridol), you are strongly encouraged to contact us now. There is no charge and no obligation. If we take your case, there is no fee for our services unless we win your case or settle it in your favor.

On the other hand, if you fail to protect your legal rights now, you may lose the right to be compensated for your harm. (Persons seeking to preserve any potential legal claims should contact an attorney promptly, since all states have mandatory time periods in which lawsuits must be filed with the courts; otherwise, they may be forever barred.)

Digitek Digoxin Recall Attorney Lawyer

16 May, 2008 No Comment

Digitek® (digoxin tablets), a drug used to treat heart failure and abnormal heart rhythms has been linked to Digitalis toxicity. Digitalis toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Death can also result from excessive Digitalis intake.

If you or a loved one have taken Digitek and suffered any of the signs of Digitalis toxicity, you should contact us immediately. You may be entitled to compensation and we can help.

What’s the problem?

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.

According to reports, patients taking Digitek or Digoxin are receiving phone calls from their pharmacist and/or letters from their pharmacy advising them of the recall.

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 reported to the Food & Drug Administration (FDA).

Do I Have a Digitek® Recall Lawsuit?

The Defective Drug & Products Liability Litigation Groups at our law firm are an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in defective drug lawsuits. We are pursuing individual litigation nationwide and currently accepting new Digitek recall and Digitalis toxicity cases in all 50 states.

Join One to Make Poverty History - www.pangeaday.org

9 May, 2008 No Comment

The Contract Dye Manufacturer’s Letter on Gadolinium

24 Apr, 2008 No Comment

Manufacturers of Gadolinium-based contrast dyes issued a Dear Healthcare Professional letter to doctors about an addition of a WARNING and revisions to the WARNING section of the prescribing information for Gadolinium-based contrast agents used in Magnetic Resonance Imaging (MRI).

It reads:

Dear Healthcare Professional,

Post-marketing reports show that the use of these agents increases the risk of the development of a serious medical condition called Nephrogenic Systemic Fibrosis (NSF), in patients with acute or chronic severe renal insufficiency (glomerular filtration rate <30mL/min/1.73m2) and patients with renal dysfunction due to the hepatorenal syndrome or in the perioperative liver transplantation period.

NSF leads to excessive formation of connective tissue in the skin and internal organs.

NSF is progressive and may be debilitating or fatal. As of today, the FDA has received reports of over 250 cases of NSF after administration of gadolinium-based contrast agents.As a result of these NSF cases, the package inserts of all gadolinium-based contrast agents have been revised to include the following Boxed Warning and update to the WARNINGS section.

The manufacturers of gadolinium-based contrast agents would like to inform you of important revisions to the prescribing information for the products listed in alphabetical order above. Gadolinium-based contrast agents are approved by the U.S. Food and Drug Administration (FDA) for use in magnetic resonance imaging (MRI).

Call 1-800-FDA-1088 (1-800-332-1088)

For more information, contact the Gadolinium Lawyers and Attorneys at Beth Klein, P.C. You can contact us through this link GADOLINIUM LAWYER HELP.

Gadolinium Lawyers, Lawsuits, NSF, NSD, and Contrast Dye- the Basics

19 Apr, 2008 No Comment

Today, www.USRecalNews.com featured an article on the basics about Gadolinium Lawyers, NSF, NSD and Contrast Dyes written by our law firm. The article can be accessed if you click on GADOLIUM HEALTH ALERT.

Magnetic resonance imaging (MRI) uses radiofrequency waves and a strong magnetic field rather than x-rays to provide detailed pictures of internal organs and tissues. The MRI is valuable for the diagnosis of a number of conditions in all parts of the body, including cancer, heart and vascular disease, stroke, and joint and musculoskeletal disorders.

Because MRI can give clear views of soft-tissue structures near and around bones, it is the most sensitive exam for spinal and joint problems, and its is used to diagnose sports-related injuries, especially those affecting the knee, shoulder, hip, elbow, and wrist. The images allow the physician to see even very small tears and injuries to ligaments and muscles. MRIs of the heart, aorta, coronary arteries, and blood vessels is used to diagnose coronary artery disease and heart problems. Doctors can examine the size and thickness of the chambers of the heart, and determine the extent of damage caused by a heart attack or progressive heart disease. Organs of the chest and abdomen—including the lungs, liver, kidney, spleen, pancreas, and abdominal vessels—can also be examined in high detail with MRI, enabling the diagnosis and evaluation of tumors and functional disorders.

Gadolinium looks clear like water and is non-radioactive. After it is injected into a vein, Gadolinium accumulates in the abnormal tissue that may be affecting the body or head. Gadolinium causes these abnormal areas to become very bright (enhanced) on the MRI. This makes it very easy to see.

The problem occurs when Gadolinium cannot be excreted by the body. This occurs in patients who have kidney problems.

Further, Gadolinium based contrast agents should only be used in pregant and nursing women with great caution.

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