Pansy Mae Christian, who suffered from a cardiac condition, died on November 8, 2007 after taking Digitek prescribed by her doctor. On May 2008, Christian’s estate administrator James R. Christian received notice of the drug’s recall and complaints about significant adverse side effects.

On January 15, 2008, Gary Lucineo suffered toxicity and died after taking Digitek prescribed by his physician for congestive heart failure. His estate administrator, Jeanette Lucineo, is suing the companies, claiming they failed to warn users of the drug that the medication was provided for use by the public with twice the approved level of active ingredient. That overdose caused toxicity that the suit claims contributed to Mr. Lucineo’s death.

In April 2005, Actavis Totowa LLC, initiated a nationwide Class I recall of Digitek after it learned that oversized tablets had been distributed, which likely contained twice the level of active ingredient. Taking more than the FDA-approved level of Digitek can lead to Digitek toxicity, also known as digitalis toxicity, a serious and life-threatening complication. Symptoms of digitalis toxicity include unusual visual changes, confusion, loss of appetite, nausea, vomiting or diarrhea, palpitations or irregular pulse.

If you are taking digitalis medications and symptoms of digitalis toxicity develop, contact your healthcare provider immediately.

SOURCE: Digitek Recall › Two lawsuits filed against makers of Digitek heart medication

Digoxin is a drug product used to treat heart failure and abnormal heart rhythms. A higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability. Caraco is recalling these tablets to the consumer level to minimize any potential risk to patients.

Last year, Actavis Totowa LLC, a generic pharmaceutical company initiated a Class 1 recall on Digitek brand digoxin tablets when it was learned that some tablets were oversized and contained twice the level of active ingredient, putting consumers at risk.

Consumers of Caraco’s digoxin tablets that fall within the recall should return these products to their pharmacy or place of purchase. Patients who have medical questions should contact their healthcare provider for additional instructions or guidance.

Source: FDA

SOURCE: Digitek Recall › Caraco brand digoxin recalled; could put consumers at risk

Watson Pharmaceuticals, Inc., announced the voluntary recall of Propafenone HCL 225 mg tablets sold in 100-count bottles in the United States. The affected tablets were sold to customers between October 15, 2008 and November 26, 2008. No other strengths or lots were affected and the company does not anticipate any product shortages as a result of this recall.

Propafenone is a drug product used to treat cardiac arrhythmias, or irregular heartbeats. It has a narrow therapeutic index, so some patients who are particularly sensitive to small variations in dose may experience potentially serious side effects, including arrhythmias (irregular heartbeat) or low blood pressure.

Watson is recalling the lot at the consumer level as a precautionary measure to minimize any potential risk to patients. Patients using 225 mg Propafenone HCL tablets who have medical questions should contact their health-care provider.

Last spring, generic drug maker Actavis Totowa LLC issued a Class 1 recall of its digoxin heart medication Digitek. A Class 1 recall is the most serious type of recall and involves situations in which there is a reasonable probability that use of the product will cause serious injury or death. The recall came after the company discovered oversized tablets containing twice the level of active ingredient.

Source:
FDA

SOURCE: Digitek Recall › FDA recalls another heart medication for oversized pills

Some of the products, such as Dextroamphetamine Sulfate generally prescribed for narcolepsy and attention deficit disorder with hyperactivity, fell under an earlier recall due to defects such as oversized tablets delivering higher than labeled doses of medication. The expanded recall is to ensure that all defective products have been removed from the market.

Oversized tablets also plagued U.S. generic pharmaceutical group Actavis Totowa LLC, which recalled batches of Digitek last April.  Digitek is commonly used in the treatment of various heart conditions.

ETHEX has recall notifications to wholesalers for several drugs and to pharmacy retailers for Hydromophone HCI and Metoprolol Succinate only. Hydromophone HCI is a analgesic drug from the opioid class drug often used as an alternative to morphine. Metoprolol Succinate is a medication used to treat several conditions related to the heart and blood vessels. A complete listing of medications recalled is available from the FDA.

Patients who have any of these medications in their possession are advised to continue taking them in accordance to their prescriptions, as suddenly stopping them could put patients at risk. Patients also should contact their health care provider if they experience any problems or have questions about their prescriptions.

Any wholesale or retail customer inquiries related to this action should be addressed to ETHEX Customer Service at 1-800-748-1472, faxed to ETHEX Customer Service at 314-646-3788, or e-mailed to customer-service@ethex.com. Representatives are available Monday through Friday, 8 am to 5 pm CST.

SOURCE: Digitek Recall › ETHEX expands voluntary recalls

According to the Associated Press, the suit requests the court to not allow Actavis Inc. and Actavis Totowa to manufacture drugs until the company complies with FDA regulations for testing, quality control, and test response. The company must also stop selling unapproved and misbranded drugs.

Filed by U.S. Attorney Christopher Cristie and the Department of Justice’s Officer of Customer Ligation, the suit states Actavis’ facilities in Totowa and Little Falls, N.J., have not only continued to fail FDA examinations, but Actavis has not made the required changes.

Between January 2006 and May 2008, the FDA examined the two facilities in Totowa and the one in Little Falls five times overall.

In April of 2008, Actavis recalled its heart drug Digitek due to pills being twice as thick as the original form. Due to the doses being doubled, Digitek posed a threat to its consumers.

The FDA discovered in the inspections that Actavis did not have complete lab records of its testing information, and did not verify that its testing methods “matched up with actual conditions under which the products would be used.”

These are just a few of many violations that continued throughout FDA inspections of Actavis.

SOURCE: Digitek Recall › U.S. attorneys sue makers of Digitek, seek to close facilities

Dingell and Stupak’s letter questions not only the FDA’s inspection of the company’s facilities, but if the FDA should have allowed this company to resume its operation, even though it has a history of recalls.

According to PharmTech, Congress wants the FDA to provide documents “on all FDA-regulated products that Acatavis received approval to sell in the United States since January 1, 2003.”

At the end of July, Actavis Totowa decided to voluntarily recall “the retail level of all drug products manufactured at its Little Falls, New Jersey, facility.” This recall took place after the FDA conducted an inspection of the company in April when Digitek was recalled because the pills were double in “the appropriate thickness.” In this third recall, the recalled pills are believed to have contained twice the correct amount of medication.

Digitek is not the only product that Actavis has recalled; in March, Actavis South Atlantic LLC recalled U.S-sold fentanyl transdermal system CII patches. They may have “a fold-over defect,” which may leak fentanyl gel.

The Actavis Group is not only the producer of Digitek but also many other products. According to Actavis’ website, Actavis is “one of the world’s leading players in first-class generic pharmaceuticals.” We will see just how much longer this statement remains to be true.

SOURCE: Digitek Recall › Congress investigates FDA inspection of Actavis

Across the United States, around sixty Digitek recall law suits have been filed in federal courts. The defendants include the following: Actavis Totowa, LLC, Actavis, Inc., Actavis Elizabeth, LLC, Actavis US, Mylan, Inc., Mylan Pharmaceuticals, Inc., Mylan Laboratories, Inc., Mylan Bertek Pharmaceuticals and UDL Laboratories, Inc.

Collective cases will be transferred to Judge Joseph R. Goodwin.

According to the news report, under federal court procedures, the purposes of transferring all cases to one judge for pretrial rulings eliminates duplicative discovery and inconsistent pretrial rulings. Unlike a “class action,” where all suit are tried together, the MDL relates to pre-trial actions only. If a resolution or settlement is not reached, the cases go back to their respective districts for trial.

SOURCE: Digitek Recall › MDL consolidates Digitek recall cases

Digitek was recalled in April 2008 after it was discovered that tablets may have been manufactured at twice their intended thickness, doubling the amount of medication in the pills and putting patients at risk for serious complications as a result of higher dosages than intended.

Actavis acknowledged the recent FDA review revealed the Little Falls facility did not meet the company’s own standards for good manufacturing practices, the release says. As a result, Actavis made the decision to recall products manufactured at that facility at the pharmacy/retail level, including wholesalers and hospitals. Actavis has notified the FDA of this action.

There have not been any product complaints or health hazards reported with products affected by this recall, all of which are prescription medications. The manufacturer recommends that patients currently taking the affected medications should not stop taking the drugs, as a sudden stop in medication could be dangerous, but patients should consult with their physician or pharmacist for replacement medication.

Actavis Totowa has issued recall letters to wholesalers and retailers. There are more than 65 drugs affected by this recall. If you currently take any of these drugs, you should contact your pharmacy for a replacement:

Amantadine 100mg capsules

Amibid DM ER tablets

Amibid DM tablets

Amidrine capsules

Amigesic 500 mg caplets and 750 mg caplets

Amitex PSE tablets

Bellamine S tablets

Betaxolol 10 mg and 20 mg tablets USP

Buspirone HCL 5 mg, 10 mg, 15 mg and 30mg tablets

Carisoprodol & Aspirin tablets

Carisoprodol 350mg tablets

Carisoprodol, Aspirin & Codeine tablets

Chlordiazepoxide w/ Clidinium Bromide capsules

Chlorzoxazone 250mg

Choline Magnesium Trisalicylate 500 mg, 750 mg and 1000 mg tablets

Cilostazol tablets 100mg

Cyclobenzaprine HCL 5 mg and 10 mg

Dexchlorpheniramine Maleate 4 mg and 6 mg tablets

Dipyridamole 25 mg, 50mg, and 75 mg tablets

Glyburide 1.5 mg, 3.0 mg and 6.0 mg tablets

Guaifenesin & Codeine Phosphate tablets

Guaifenesin & Phenylephrine tablets

Guanfacine 1.0 mg and 2.0 mg HCl tablets

Hydrocodone & Homatropine tablets

Hydromorphone HCl tablets

Hydroxyzine 10 mg, 25 mg and 50 mg tablets

Hyoscyamine Sulfate 0.125 mg (oral) tablets

Hyoscyamine Sulfate 0.125 mg SL

Hyoscyamine Sulfate 0.375mg SR tablets

Isradipine 2.5 mg and 5 mg capsules

Loxapine 5 mg, 10 mg, 25 mg, and 50 mg capsules

Meclizine Chewable 25 mg tablets

Meloxicam 7.5 mg and 15 mg tablets

Meperidine & Promethazine capsules

Meperidine HCl 100 mg and 50 mg tablets

Methenamine Mandelate 0.5 g and 1.0 g tablets

Mirtazapine 15 mg, 30 mg, and 45 mg tablets

Mirtazapine OD tablets, 15 mg, 30 mg and 45 mg

Multi-ret Folic 500 mg tablets

Multi-vita-bets 0.25 mg, 0.5 mg and 1 mg FL tablets

Multi-vita-bets 0.5 mg and 1.0 mg FL & FE tablets

Naltrexone 50mg tablets

Oxycodone & Acetaminophen 5/500mg capsules

Oxycodone HCl 5 mg capsules

Oxycodone HCl 5 mg, 15 mg and 30 mg tablets

Pentazocine & Acetaminophen tablets

Pentazocine & Naloxone tablets

Phenazopyridine HCl 100 mg and 200 mg tablets

Phendimetrazine Tartrate 35mg tablets

Phentermine HCl 15 mg, 30 mg and 37.5 mg capsules

Phentermine HCl 37.5 mg tablets

Prenatal Formula 3 tablets

Prenatal Plus 27 mg FE tablets

Prenatal Rx tablets

Quinaretic 10mg/12.5mg, 20 mg/12.5 mg and 20 mg/25 mg tablets

Rifampin 300mg capsules

Sodium FL 0.5 mg and 1.0 mg tablets

Tizanidine HCl 2 mg and 4 mg tablets

Trimethobenzamide 300mg capsules

Trimipramine Maleate 25mg, 50mg, 100mg capsules

Trivita 1 mg FL tablets

Ursodiol capsules, 300mg

Vitacon Forte capsules

Vitaplex Plus tablets

Vitaplex tablets (FC)

Yohimbine HCl 5.4 mg tablets

For more information, visit Actavis Totowa online.

This is not the first time Actavis has been cited by the FDA for improper procedures.

The FDA sent a warning letter to Actavis in August 2006, alerting the company that its manufacturing facility in New Jersey had failed to file periodic safety reports, and had failed to report adverse drug events. Actavis was reprimanded for marketing drugs without proper clearance by not submitting the safety reports.

SOURCE: Digitek Recall › Actavis recalls more than 65 drugs

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

SOURCE: Digitek Recall › Pharmacists will call: Digitek recalled