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

Digitek, a brand of digoxin, is a widely used treatment for various heart conditions such as atrial fibrillation, atrial flutter and heart failure.

According to the complaint, the companies received a warning from the Food and Drug Administration (FDA) that they failed to provide periodic safety reports for the facility where the medication was manufactured. By failing to provide the safety reports, the companies violated their adverse medical event reporting obligations. The FDA also warned that the drugs were being marketed without proper clearance and that at least 26 adverse events with the drug had not been reported.

In 2008, the FDA issued an alert to the public of a recall of Digitek, after it was found that some tablets had been distributed at double the thickness. Those oversized pills were thought to contain double the active ingredient. As a result, some patients experienced digoxin toxicity, which can result in life-threatening complications.

The complaint states, “The recalled Digitek was adulterated, misbranded, defective, unreasonably dangerous and unfit for its intended use.” Plaintiffs also contend that Actavis and Mylan Pharmaceuticals “placed tens of thousands of patients, including Decedent, unnecessarily at risk of serious injury and/or death and may have caused them to suffer personal injuries and harm, including medical expenses, anxiety and fear induced from ingesting the defective and misbranded drug.” The plaintiffs are asking for a trial by jury.

Source: The Southeast Texas Record

SOURCE: Digitek Recall › Product liability lawsuit filed against Digitek manufacturer, distributor

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

The fact sheets will be used in court to determine whether Mylan Pharmaceuticals of West Virginia, Actavis US and DUL Laboratories misrepresented Digitek as safe and whether physicians and patients relied on those “misrepresentations and deceptions” in choosing to use the heart medicine.

Digitek is used in the treatment of various heart conditions such as atrial fibrillation, atrial flutter and heart failure. In 2008, the FDA issued an alert to the public of a recall of Digitek, after it was found that some tablets had been released at double the thickness, which were thought to contain double the active ingredient. As a result, some patients experienced digoxin toxicity, which can result in life-threatening complications.

The lawsuit argues that, “Plaintiffs have sustained severe physical injuries and/or death, severe emotional distress, mental anguish, economic losses and other damages for which they are entitled to compensatory and equitable damages.”

The fact sheets require plaintiffs to detail 10 years of medical history including the names of every doctor who saw them, every hospital that admitted them and every pharmacy that dispensed medications to them, as well as providing full disclosure for psychological disorders, substances abuse and acquired immune deficiency syndrome. They also are required to list all drugs they have taken and list possible side effects, complete a chart of diagnoses of family members, and state how much they smoke, how long they have smoked, and how much and how often they drink alcohol. They must complete charts of Digitek or Lanoxin pills usage. And, plaintiffs must submit job records including pensions and insurance and disclose all workers compensation claims, disability claims and personal injury lawsuits.

To date, more than 100 Digitek lawsuits have been transferred to U.S. District Judge Joseph Goodwin, and more are expected to be added.

SOURCE: Digitek Recall › Those suing for Digitek injury must fill out lengthy fact sheets

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

Digitek is a medication widely used to treat heart conditions that cannot be controlled by other medications. Incorrect dosing of the medication can be dangerous, and sometimes fatal. In April 2008, Digitek’s manufacturers issued a nationwide recall because the pills contained twice the amount of the active ingredient. The oversized pills posed a serious risk of digoxin toxicity especially in patients with renal failure.

On behalf of her husband, Rosina Michna has filed a lawsuit alleging medical negligence against the doctor who initially prescribed Digitek but didn’t monitor his blood levels. She also is suing the numerous pharmaceutical companies involved in the manufacture, marketing and distributing of Digitek for negligence, according to the Marin Independent Journal.

An initial hearing of the lawsuit is set for April 27, 2009.

SOURCE: Digitek Recall › Widow files suit against doctor, pharmaceutical companies

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

The complaint further states the FDA letter, written in Aug. 2006, advised defendants they were promoting drugs “without proper clearance” and possibly more than 26 adverse drug experiences went unreported.

The updated FDA letter in February 2007 states, “Significant deficiencies were found in the operations of your firm’s quality control unit, and as a result there is no assurance that many drug products manufactured and released into interstate commerce by your firm have the identity, strength, quality and purity that they purport to possess.”

In April of 2008, Digitek‘s manufactures issued a recall because the pills contained twice the amount of the active ingredient.  In response to recall, the plaintiff argues, “Defendants placed tens of thousands of patients, including Decedent, unnecessarily at risk of serious injury and/or death and may have caused them to suffer personal injuries and harm, including medical expenses, anxiety and fear induced from ingesting the defective and misbranded drug.”

In the Digitek lawsuit, Butts filed the following charges: “violation of the Texas Deceptive Trade Practices Act, strict product liability including design and manufacturing defects, failure to warn, breach of express and implied warranty, negligence, fraud, negligence per se, and negligent misrepresentation.”

Butts is also desiring “damages for pecuniary losses, all hospital, medical and funeral expenses, loss of advice and counsel, loss of spouse’s services and parent’s services, mental anguish, loss of companionship and society, and loss of inheritance.”

SOURCE: Digitek Recall › Texas woman sues Digitek manufacturer for husband’s death

Chandler’s wife Barbara Chandler deems the defendants negligent because Digitek was distributed to the public with twice the amount of the active ingredient, according to the West Virginia Record.

The paper reports, “Digitek (Digozin) has a narrow therapeutic index and has a limited margin between effectiveness and toxicity. Chandler, as administratix of the estate is seeking judgment, jointly and severly, (sic.) from all defendants, pre and post judgment interest and costs.”

SOURCE: Digitek Recall › Alabama man dies after consuming 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 Philadelphia Inquirer, the agreement says Actavis cannot resume its practices until it conforms to “the agency’s good manufacturing practice.” Actavis must improve its labs, facilities, and equipment.

Actavis has faced numerous lawsuits over the recalled drug Digitek. One such lawsuit includes the death of a patient and claims that Digitek is an unsafe and flawed drug.

Actavis would not comment if the FDA agreement had influenced the Digitek lawsuits or not.

SOURCE: Digitek Recall › Actavis N.J. plant agrees with FDA

In April of this year, Digitek pills were recalled due to a suspicion of Digitek pills containing twice the active ingredient. Actavis Inc., the drug manufacturer, believes none of these pills made it to the public and that the recall was only out of “an abundance of caution.”

Unfortunately, many Digitek consumers are still unaware of the Digitek recall and the number of reported deaths associated with Digitek consumers. The FDA posted a Med Watch Alert for Digitek on April 28, 2008 due to the possibility of some of the pills containing double the active ingredient.

Health experts believe the FDA should have further investigated Digitek’s manufacturers and the FDA should have warned doctors, pharmacists, and consumers of the potential dangers associated with this drug. The FDA believes their actions in informing the public were consistent when compared to other drugs that have caused issues.

SOURCE: Digitek Recall › Digitek believed responsible for 667 deaths

According to the West Virginia Record, Goodwin wrote, “Some complaints in this MDL action join multiple plaintiffs whose only apparent connection with one another is that they ingested the drug at issue.”

Goodwin gave all plaintiff lawyers a Dec. 31 deadline “to identify all multi-plaintiff actions subject to his order and propose a severance order.”

After the 30 days of separation, the plaintiff must file a revised complaint. Goodwin wrote, “The severed and amended complaint must contain the specific claims asserted by the plaintiffs named in it.”

In cases of husbands and wives as plaintiffs, Goodwin won’t sever the cases.

For deaths and illnesses associated with Digitek, plaintiffs seek compensation from the Digitek drug companies Mylan Pharmaceuticals of West Virginia and Actavis Group.

SOURCE: Digitek Recall › Goodwin to seperate federal digitek complaints

According to the West Virginia Record, the suit claims, “Digitek contains twice the approved level of active ingredient and a narrow therapeutic index, which means the medication has a limited margin between effectiveness and toxicity.”

Digitek has a negative history.  Since 2006, 11 or more complaints have been recorded about the dangerous side effects of the drug, which include injuries and diseases.

At this time, Digitek is the only heart medication that is supposed to correct atrial fibrillation, atrial flutter and heart failure. Instead of correcting these problems, Digitek has unfortunately lead some consumers to their deaths and has also affected numerous loved ones in the process.

Being filled with mental agony and grief are just a few ways John Anthony Conte has suffered in losing his wife to Digitek ingestion. Though John Anthony Conte seeks compensatory and punitive damages for his wife’s estate, his wife cannot be replaced.

SOURCE: Digitek Recall › Kentucky man files digitek suit after losing wife

Actavis claims that it has been dedicated to ensuring the value and integrity of its manufacturing since May 2008, which is after the FDA inspected Actavis because the company manufactured Digitek pills that were twice as thick as they ought to have been.

According to Market Watch, “The company views the filing of this complaint as one step in a long regulatory process, and is fully committed to working collaboratively and openly with the FDA in a timely manner.”

John LaRocca, Actavis Inc.’s Chief Legal Officer, says in response to the claim, “We have taken a comprehensive approach to correcting all deficiencies within the Totowa business, and we’ve communicated regularly and candidly with the FDA, the public, our employees and our customers. Last month, we asked FDA to return to the Totowa facilities, conduct an inspection, and observe the substantial progress we have made. To this point, the FDA has not acted. Our company takes these matters very seriously, and we remain focused on quality, innovation, and product safety. We look forward to a quick and satisfactory resolution to these issues for the benefit of consumers, the agency, and ourselves.”

SOURCE: Digitek Recall › Actavis comments on lawsuit

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

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

Journal editor Dr. Jeffrey M. Drazen says the litigation process and the court system is a “key defense mechanism” to insure drug safety and to obtain justice if drug manufacturers have not made the risks involved with its product clear.

The doctors say the FDA is incapable of being the sole guardian of drug safety and that without the information supplied by liability litigation, “the American public would be deprived of a vital deterrent against pharmaceutical company misconduct.”

The opinion was submitted to the Supreme Court as a friend-of-the-court brief in the matter of Wyeth v. Levine, a case expected to be heard later this year. According to the AP story, the case involves Diana Levine, a guitarist who lost her right arm below the elbow after an injection of Phenergan. She sued the drug’s manufacturer, Wyeth, alleging the company had not adequately warned consumers of the risks associated with its product. The case was tried in Vermont, and the court agreed, awarding Levine $7 million.

Wyeth is appealing the case, saying the FDA had approved the drug, and that the state court could not overrule the FDA’s judgment.

However, the editors of the New England Journal of Medicine sided with 47 state attorneys general and two former FDA commissioners in supporting Levine’s position, the AP report states.

SOURCE: Digitek Recall › doctors support drug safety litigation

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