Actavis Inc.

Digitek was cited by the Center for Public Integrity as the “primary suspect” in 667 deaths reported between April 1, 2008 and June 30, 2008. Digitek is prescribed for various heart conditions such as atrial fibrillation, atrial flutter and sometimes heart failure. An incorrect dosage or overdosage can be dangerous and even fatal to heart patients taking the medication, causing even more cardiac instability and compounding existing problems.

Last April, it was discovered that some tablets produced in the Actavis New Jersey plant were oversized and contained as much as twice than the marked dosage of the active ingredient. A massive recall was ordered and Actavis contends that none of the oversized pills reached consumers. The New Jersey plant was officially closed in August to correct its shoddy manufacturing practices, and in November the U.S. Justice Department ordered the plan remain closed until it could prove it has met the FDA’s “Good Manufacturing Practice.”

In January, the FDA announced that it would allow Actavis to resume its production of Digitek provided it proves it has cleaned up its act. Actavis signed the proposed consent decree but whether it will start making Digitek again is anyone’s guess.

A division of the Icelandic Actavis Group, Actavis is among of the world’s five largest drug makers.

SOURCE: Digitek Recall › Actavis signs consent decree to resume making Digitek

The FDA filed an action against Actavis Dec. 23, which was signed by Actavis on Dec. 29. The FDA awaits a permanent injunction against this company. The FDA declares Actavis and its officers have been manufacturing and distributing “unapproved” drugs in the U.S. The FDA promotes pharmacists to stop dispensing unapproved Digitek drugs.  The FDA strongly encourages Digitek consumers to discuss alternative plans with their doctors.

Janet Woodcock, director of  FDA’s center for Drug Evaluation and research, stated, “The FDA will not allow manufacturers to put the public’s health at risk. These unapproved new drugs have not undergone FDA review for safety and efficacy and may pose potential health risks.”

John LaRocca, Actavis’s chief legal officer, said, “We have been working with the FDA to address compliance issues at the Totowa facilities. We have an entirely new management team in place at Little Falls, [New Jersey], and have invested significantly to reinforce systems and procedures intended to better ensure robust, sustainable compliance. This agreement with the agency is a positive step and is one we have looked forward to reaching. We will continue to work with the FDA to show that we have addressed all of the agency’s compliance and manufacturing issues.”

SOURCE: Digitek Recall › FDA awaits Actavis permanent injunction

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

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