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

As with the previous recall of some 60 generic drug products, the products are being recalled because the generic products may have been manufactured under conditions that “did not sufficiently comply with current Good Manufacturing Practices,” according to a follow-up press release issued Wednesday by the FDA.

Some medicines on ETHEX’s earlier list of recalled products include Digitek, a common treatment for heart conditions, and Dextroamphetamine Sulfate, a medication generally prescribed for narcolepsy and attention deficit disorder with hyperactivity.

Both medications were recalled in 2008 after oversized tablets were discovered in some batches. Such defects may deliver higher than labeled doses of medication and can cause serious, life threatening conditions in patients who take them.

ETHEX says the expanded recall is to ensure that all defective products have been removed from the market.

A complete listing of recalled generic products can be viewed on ETHEX’s January 28 press release, ETHEX’s February 4 follow up press release, and Ther-Rx Corporation’s release.

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 healthcare provider if they experience any problems or have questions about their prescriptions.

SOURCE: Digitek Recall › ETHEX issues update to earlier recall, prenatal vitamins added to list

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

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

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

Because digoxin was not recalled, this company has been able to maintain a good financial report for the fourth quarter of the fiscal 2008 year. Especially after the Digitek recall, the company continues to work with the FDA to guarantee a safe and immense supply of this product.

Established in 1942, Lannett Company, distributing generic products for various symptoms, is a popular leader in the pharmaceutical industry. Lanett sells its products to drug wholesalers, retail drug chains, repackagers, distributors, and government agencies.

Digoxin has proven to be a safe and popular alternative to the recalled Digitek.

SOURCE: Digitek Recall › Generic drug maker reaps benefits of Digitek recall

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