Yourlawyer.com (Actavis Recall News)

Actavis Reopens Plant Closed After Digitek, Other Drug Recalls

Mon, 20 Apr 2009 00:00:00 -0700

Actavis Totowa has received approval from the Food & Drug Administration (FDA) to reintroduce Oxycodone tablets made at its Little Falls, NJ facility. The Little Falls plant was one of three closed last year following recalls of oversized Digitek (Digoxin) tablets and other defective generic drugs.

Actavis agreed to temporarily close its Little Falls manufacturing facility, as well as another in Riverview and a packaging plant in Taft as part of a Consent Decree it reached with federal regulators. Last April, Actavis recalled Digitek tablets, some of which were made in Little Falls. Actavis said at the time that some Digitek tablets might have been oversized, and could expose patients to a dangerously high level of the drug’s active ingredient. The FDA deemed the Digitek recall a Class I recall, meaning that the defective Digitek tablets could cause serious health problems or death. A double-strength Digitek tablet poses a serious risk of digitalis toxicity in those patients suffering from renal failure.

Finally in August, Actavis issued another recall of all generic drugs made at the Little Falls facility. That recall was prompted by an inspection at the facility which revealed that operations did not meet the FDA’s standards for good manufacturing practices.

A report issued in December by the Center for Public Integrity found that the number of fatalities associated with Digitek spiked around the time of the recall. According to the report, there were 667 deaths reported to the FDA Adverse Events Reporting System that involved Digitek between April 1 and June 30. The group also found that FDA had received just one reported death attributed to Digitek in the previous three-month reporting period. The Center says the FDA has confirmed the findings of its analysis.

After the August recall, Actavis finally closed the New Jersey plants to institute “remediation” efforts. But the company sought to reopen the facilities, prompting the Justice Department to file a lawsuit in November to force their closure. Under the Consent Decree reached the following month, Actavis agreed to not distribute any products from the closed facilities until it has certified completion of certain enumerated requirements that demonstrate compliance with FDA’s current good manufacturing practice and has passed follow-up FDA inspections of the facilities. The Consent Decree settled issues identified by the Justice Department lawsuit.

According to an Actavis press release issued late Friday, the FDA completed its inspection of Little Falls and approved the release of the first two products as outlined in the Decree: Oxycodone 15 mg and 30 mg tablets. Subsequent inspections, also as outlined in the Decree, will follow, the release said.

"Through an extensive process, Actavis re-qualified all equipment and utilities for production and packaging - and we re-qualified and revalidated all methods used to release products from our Totowa facilities," Nasrat Hakim, Vice President of Quality Compliance and Technical Services for Actavis Inc. said in the company's statement. "This is a very positive step and took incredible team work. The next step in the process will involve additional interaction with the FDA so that we can continue to introduce products as outlined in the Consent Decree."

Following Digitek, Other Drug Recalls, Feds Seek to Shutter Actavis Facilities

Tue, 18 Nov 2008 00:00:00 -0800

Actavis Totowa, LLC, the maker of defective Digitek tablets, now faces a lawsuit filed by the U.S. Justice Department that seeks to shut down substandard manufacturing plants in New Jersey.

In April 2008, Actavis Totowa recalled Digitek tablets because some of the medication contained twice the active ingredient normally found in Digitek. According to the Food & Drug Administration (FDA), the Digitek defect could cause serious and even fatal reactions in users. The FDA deemed the Digitek recall a Class I recall, its most serious recall.

In August, Actavis issued another recall of all generic drugs made at its Little Falls, N.J. facility. The recall was prompted by an inspection at the facility which revealed that operations did not meet the FDA’s standards for good manufacturing practices. The Little Falls factory also produced some of the faulty Digitek recalled earlier.

According the Justice Department lawsuit, the FDA conducted five inspections of three Actavis facilities in Totowa and Little Falls, New Jersey over the last three years. Despite written warnings to the company, during its last inspection this year, the FDA continued to find numerous and recurring violations of Good Manufacturing Practice requirements. The FDA also found that the company continued to manufacturer and distribute unapproved new drug products, the complaint says.

The complaint also states that during its most recent inspection this year, the FDA found that Actavis Totowa's failure to comply with the Good Manufacturing Practice requirements resulted in, among other things, the company's release of the defective Digitek tablets

According to a Department of Justice press release, Actavis recently informed that FDA that they would like to restart manufacturing drug products at the New Jersey facilities. However, the Justice Department said that Actavis has not demonstrated to the FDA that it can do this in compliance with the Good Manufacturing Practice requirements.

The lawsuit seeks a permanent injunction to bar Actavis Totowa and Actavis Inc, as well as two of their officers, from the manufacturing and distribution of generic drug products until they demonstrate compliance with the Good Manufacturing Practice requirements of the Federal Food, Drug and Cosmetic Act.

"FDA and the Justice Department are committed to ensuring that drugs sold in the United States are safe and effective," Gregory Katsas, Assistant Attorney General for the Justice Department's Civil Division, said in the press release. "As part of this commitment, we have and will continue to file injunction actions to enforce strict compliance with Good Manufacturing Practice requirements."

Digitek, Other Generic Drug Recalls Prompt Congressional Probe of Actavis Totowa

Fri, 10 Oct 2008 00:00:00 -0700

Actavis Totowa, the company that has recalled a variety of drugs this year, including Digitek tablets and fentanyl patches, has attracted the attention of lawmakers on the House Energy and Commerce Committee. Chairman John Dingell (D-Mich.) and Oversight and Investigations Subcommittee Chairman Bart Stupak (D-Mich.) have sent a letter to the Food & Drug Administration (FDA) seeking information about the Actavis recalls.

In April 2008, Actavis Totowa recalled Digitek tablets because some of the medication contained twice the active ingredient normally found in Digitek. According to the FDA, the Digitek defect could cause serious and even fatal reactions in users. The FDA deemed the Digitek recall a Class I recall, its most serious recall.

In August, Actavis issued another recall of all generic drugs made at its Little Falls, N.J. facility. The recall was prompted by an inspection at the facility which revealed that operations did not meet the FDA's standards for good manufacturing practices. The Little Falls factory also produced some of the faulty Digitek recalled earlier.

When the Actavis generic drug recall was announced, the FDA said that products made at the company's other manufacturing facilities were not suspect. But in a letter to FDA Commissioner Andrew von Eschenbach, both Dingell and Stupak questioned that assertion. They note that at least one other Actavis unit, Actavis Atlantic, LLC, had recalled fentanyl pain patches in February 2008 because of a dangerous manufacturing defect.

Their letter asks von Eschenbach to provide their Committee with all information pertaining to all FDA-regulated products that Actavis has received approval to sell since January 2003, as well as all drugs Actavis imports to the U.S. regardless of approval date. The Congressmen want to know if the FDA was deceived by Actavis when it inspected the company's facilities, or if the agency failed to do adequate inspections.

The House Energy and Commerce Committee is also investigating the FDA's role in another generic drug scandal involving the Indian drug maker Ranbaxy. Last month, the FDA banned generic drugs made at to Ranbaxy plants in India. In addition to the import alert, the FDA said it won’t approve any drug applications that list the two suspect Ranbaxy plants as a source of ingredients.

In February, federal agents raided the US corporate offices of Ranbaxy in New Jersey, as well as a manufacturing facility in the state. The raid - and criminal investigation - was prompted, in part, by problems uncovered in FDA inspections a year earlier at the company’s plant in Paonta Sahib, India. That inspection found inconsistencies in the company’s manufacturing processes and maintenance of data.

In July, US prosecutors filed a motion in federal court in Maryland alleging that Ranbaxy forged documents relating to an investigation into the quality of the company’s drugs sold in the this country. The investigation is also looking into allegations that Ranbaxy made weak or adulterated HIV drugs that were given to thousands of AIDS patients in Africa. Prosecutors have accused the company of concealing violations of good manufacturing practice regulations from FDA.

In a letter written to the FDA this July, Dingell and Stupak wrote that court documents related to the Justice Department probes of Ranbaxy indicated that for 18 months the FDA was aware of problems but “did nothing to remove the suspect products from the market, or even notify the pharmacists in this country”.

Suit Over Phenytoin Names 10 Defendants in Womans Death

Fri, 15 Aug 2008 00:00:00 -0700

According to court papers, Agnes Davis was prescribed phenytoin and then suffered a severe adverse reaction- Stevens-Johnson Syndrome - that allegedly led to her death. Phenytoin is a generic version of Dilantin. The lawsuit, filed by Willie Davis Jr. and Alice Washington—Davis’s family members—on August. 8, 2008, names 10 companies that make, label, test, market, or distribute phenytoin. Among other issues, the defendents allege that the defendants misled and failed to adequately warn users of life-threatening side effects caused by taking phenytoin.

The complaint’s causes of action include strict product liability-failure to warn and defect in design or manufacture, fraud, breach of implied and express warranties, negligence and gross negligence. The 10 companies named as defendants are: Mylan Inc., Mylan Bertek Pharmaceuticals Inc., Mylan Pharmaceuticals Inc., Actavis Mid Atlantic, Morton Grove Pharmaceutical Inc., Taro Pharmaceuticals USA Inc., VistaPharm Inc., Barr Pharmaceuticals Inc., Ivax Pharmaceuticals Inc., Elkins-Sinn Inc., Hospira Inc., Hospria Worldwide Inc., and Baxter Healthcare Corporation.

The suit also states that Davis began taking phenytoin in June 2006. Sometime later, Davis broke out with a high fever and skin rash that resulted in blisters on her face and body. Davis was then hospitalized for several weeks at the Medical Center of Southeast Texas where she was diagnosed with Stevens-Johnson Syndrome. According to MayoClinic.com, Stevens-Johnson syndrome is a rare, serious disorder of the skin and mucous membranes and often presents with several days of flu-like symptoms, followed by inflammation of the mucous membranes, and a painful red or purplish rash that spreads and blisters, eventually causing the top layer of the skin to die and shed. The syndrome is usually a specific type of allergic reaction in response to medication or infection, according to the Mayo Cinic’s Website.

The plaintiffs allege that the defendants violated the applicable code of federal regulations by failing to include a warning that Stevens-Johnson Syndrome is a potential side effect of phenytoin. "Accordingly, Ms. Davis' prescribing physician was deprived of the ability to fully assess the risks when making the decision to prescribe the drugs due to the defendants deficient and inadequate warning," the complaint states. The plaintiffs also claim that Davis would not have taken phenytoin had the risks and dangers been disclosed, and "would not have suffered her adverse reaction and its subsequent complications."

The complaint states that because the drug hazards were hidden, the drug makers “have reaped huge profits"; that the defendants failed to perform adequate testing that would have shown that phenytoin possessed serious side effects; that the defendants should have taken appropriate measures to ensure that its defectively designed product would not be placed into the stream of commerce; that prior to manufacturing and distributing the drug, the companies "had knowledge from several sources" that the product presented substantial and unreasonable risks to the consumer; that the drug makers knowingly and deliberately failed to remedy the known defects "for the purpose of increasing sales and enhancing its profits"; and that “Defendants' conduct was wanton and willful, and displayed a conscious disregard for the safety of the public and particularly of Ms. Davis, entitling her to exemplary damages."

CEO Leaves Actavis Group

Wed, 06 Aug 2008 00:00:00 -0700

Just days after its U.S. division recalled all of its generic drugs, Icelandic drug maker Actavis Group announced that its CEO is stepping down. However, in announcing the departure of Róbert Wessman, the company made no mention of Actavis Totowa's recent safety problems, which also included an April recall of Digitek tablets.

Instead, media reports say Wessman was stepping down to focus on his investment company Salt Investment, but will continue to have a seat on the board of Actavis. Actavis’ owners apparently felt that Wessman’s interests in Salt Investment might draw his attention away from Actavis’ daily operations.

Earlier this week, Actavis Totowa announced it as recalling all of the generic drugs made at its Falls River, New Jersey facility. The recall was prompted by a Food & Drug Administration's (FDA) inspection at the facility which revealed that operations did not meet the agency’s standards for good manufacturing practices. Actavis Totowa is asking pharmacies, hospitals and retailers to return the affected prescription medications.

This week's generic drug recall was only the latest of Actavis Totowa's safety woes. In February 2007, the FDA issued a warning letter to Actavis Totowa following an inspection of the Little Falls facility completed in August 2006. The violations cited in that letter included: significant deficiencies in the company's quality control unit; laboratory notebooks that did not include all raw test data generated during testing; failure to check for accuracy the inputs to and outputs from the "Total Chrom Data Acquisition System," which was used to run the firm's HPLC instruments; quality control failed to recognize that some tablets that did not meet in-process specifications; lack of adequate procedures for conducting bulk product holding time studies; cleaning validation studies were found to be inadequate; master and batch production and control records were found to be deficient; and equipment used in the manufacture of Benztropine Mesylate tablets and other drug products was not adequately qualified.

In the warning letter, the FDA stated that it had reviewed the firm's corrective actions promised in a letter dated Aug. 29, 2006. The agency found that while corrections the firm promised in its correspondence appeared to adequately address many of the violations, the FDA reiterated its concern about the quality of drug products that were released from the facility under the serious lack of controls found during the inspection.

In April, Actavis Totowa recalled Digitek tablets because some of the medication contained twice the active ingredient normally found in Digitek. According to the FDA, the Digitek defect could cause serious and even fatal digitalis reactions in users. Some of the faulty Digitek involved in this earlier recall was made at the New Jersey facility.

The FDA deemed the Digitek recall a Class I recall, meaning that the defective Digitek tablets could cause serious health problems or death. According to the agency, there have been several reports of illnesses and injuries in patient taking Digitek. Actavis said it had 11 such reports.

Maker of Defective Digitek Recalls All Generic Drugs Made at New Jersey Factory

Mon, 04 Aug 2008 00:00:00 -0700

Actavis Totowa, the maker of defective Digitek tablets, has announced a recall of all generic drugs manufactured at its plant in Little Falls, New Jersey.

According to the Food & Drug Administration (FDA) notice, the recall was prompted by an inspection at the facility which revealed that operations did not meet the FDA's standards for good manufacturing practices. Actavis Totowa is asking pharmacies, hospitals and retailers to return the affected prescription medications.

The list of recalled medications is available here. Actavis has issued this recall at the retail level only. The company says patients should continue to take their medications as directed. However, anyone who wishes to have their medicines replaced should consult their healthcare provider.

The generic drug recall is limited to Actavis Totowa products and products manufactured in other Actavis facilities are not affected.

In April, Actavis Totowa recalled Digitek tablets because some of the medication contained twice the active ingredient normally found in Digitek. According to the FDA, the Digitek defect could cause serious and even fatal digitalis reactions in users. Some of the faulty Digitek involved in this earlier recall was made at the New Jersey facility.

The FDA deemed the Digitek recall a Class I recall, meaning that the defective Digitek tablets could cause serious health problems or death. According to the agency, there have been several reports of illnesses and injuries in patient taking Digitek. Actavis said it had 11 such reports. But because not all adverse reactions are reported to the FDA or manufacturers, the true number could be much higher.

The FDA issued a warning letter to Actavis back in August 2006 for failing to provide periodic safety reports at its oral dose manufacturing plant in Little Falls, N.J.

actavis drug recall lawyer lawsuit

Mon, 04 Aug 2008 00:00:00 -0700

Actavis Totowa Generic Drug Recall Lawyers

Keywords: Actavis Drug Recall Lawyer Lawsuit

The lawyers and attorneys at our firm are currently offering free case evaluations to individuals injured by defective generic drugs manufactured by Actavis Totowa LLC at its Falls River, New Jersey facility. On August 1, 2008, Actavis Totowa recalled all generic drugs made at that facility because of manufacturing issues. If you believe you suffered an adverse reaction from one of these recalled medications, we urge you to contact one of our Actavis Totowa generic drug recall lawyers as soon as possible to protect your rights.

The Actavis Totowa generic drug recall lawyers at our firm have learned that the company's Falls River, New Jersey manufacturing plant has been the subject of numerous safety issues in the past. This includes one other drug recall, as well as a warning letter issued by the Food & Drug Administration (FDA) in 2007 regarding inadequate conditions at the plant. Clearly, the fact that Actavis Totowa has found it necessary to recall every medication made at Falls River indicates that previous safety problems were not adequately addressed. Our Actavis Totowa generic drug recall lawyers intend to hold this company responsible for this failure.

Actavis Totowa Generic Drug Recall

The Actavis Totowa generic drug recall was initiated after an inspection of the facility revealed that operations did not meet the FDA’s standards for good manufacturing practices. Actavis Totowa asked pharmacies, hospitals and retailers to return the affected prescription medications.

The Actavis Totowa generic drug recall was initiated at the retail level only, and patients were not told to discard of their potentially defective medications. Both the company and the FDA have maintained that the recall is precautionary, and that no injuries have been reported as a result of the defective generic drugs. However, the vast majority of adverse drug reactions are never reported, and our Actavis Totowa generic drug recall lawyers believe that it is entirely possible that these shoddy medications have already injured many people.

The Actavis Totowa generic drug recall involved dozens of medications. The drugs recalled were:

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, Aspirin & Codeine tablets
Carisoprodol 350mg tablets
Chlordiazepoxide w/ Clidinium Bromide capsules
Chlorzoxazone 250mg
Cilostazol tablets 100mg
Choline Magnesium Trisalicylate 500 mg, 750 mg and 1000 mg tablets
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 SL
Hyoscyamine Sulfate 0.375mg SR tablets
Hyoscyamine Sulfate 0.125 mg (oral) 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 0.5 mg and 1.0 mg FL & FE tablets
Multi-vita-bets 0.25 mg, 0.5 mg and 1 mg FL tablets
Naltrexone 50mg tablets
Oxycodone & Acetaminophen 5/500mg capsules
Oxycodone HCl 5 mg, 15 mg and 30 mg tablets
Oxycodone HCl 5 mg capsules
Pentazocine & Acetaminophen tablets
Pentazocine & Naloxone tablets
Phenazopyridine HCl 100 mg and 200 mg tablets
Phendimetrazine Tartrate 35mg tablets
Phentermine HCl 37.5 mg tablets
Phentermine HCl 15 mg, 30 mg and 37.5 mg capsules
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

If you or someone you know have taken any of these recalled medications and suffered a side effect or injury, we urge you to contact one of our Actavis Totowa generic drug recall lawyers right away.

Previous Actavis Totowa Safety Problems

Actavis Totowa has had a history of safety problems. Months before its generic drug recall, in April 2008, Actavis recalled Digitek tablets because some of the medication contained twice the active ingredient normally found in Digitek. According to the FDA, the Digitek defect could cause serious and even fatal digitalis reactions in users. Some of the faulty Digitek tablets involved in this earlier recall were made at the New Jersey facility.

The FDA deemed the Digitek recall a Class I recall, meaning that the defective Digitek tablets could cause serious health problems or death. According to the agency, there have been several reports of illnesses and injuries in patient taking Digitek. Actavis said it had 11 such reports. But because not all adverse reactions are reported to the FDA or manufacturers, the true number could be much higher.

In February 2007, the FDA issued a warning letter to Actavis Totowa following an inspection of the Little Falls facility completed in August 2006. The violations cited in that letter included: significant deficiencies in the company's quality control unit; laboratory notebooks that did not include all raw test data generated during testing; failure to check for accuracy the inputs to and outputs from the "Total Chrom Data Acquisition System," which was used to run the firm's HPLC instruments; quality control failed to recognize that some tablets that did not meet in-process specifications; lack of adequate procedures for conducting bulk product holding time studies; cleaning validation studies were found to be inadequate; master and batch production and control records were found to be deficient; and equipment used in the manufacture of Benztropine Mesylate tablets and other drug products was not adequately qualified.

In the warning letter, the FDA stated that it had reviewed the firm's corrective actions promised in a letter dated Aug. 29, 2006. The agency found that while corrections the firm promised in its correspondence appeared to adequately address many of the violations, the FDA reiterated its concern about the quality of drug products that were released from the facility under the serious lack of controls found during the inspection.

Legal Help for Victims of Defective Actavis Totowa Generic Drugs

If you or a loved believe you were injured by a defective generic drug recently recalled by Actavis Totowa, you have valuable legal rights. Please fill out our online form or call 1-800-LAW-INFO (1-800-529-4636) to discuss your case with an experienced Actavis Totowa generic drug recall lawyer.