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."
Actavis said in a press release that the Consent Decree reached with the Food & Drug Administration settles the issues identified by the Department of Justice in its previously filed lawsuit against Actavis Inc., Actavis Totowa, and officers Sigurdur Oli Olafsson and Douglas Boothe. Under the Consent Decree, Actavis has 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 company said it anticipates that commercial production in the Actavis Totowa facilities will resume shortly.
As we’ve previously reported, the FDA issued a warning letter to Actavis back in August 2006 for failing to provide periodic safety reports at one of its oral dose manufacturing plants in New Jersey. Another FDA inspection in early 2006 revealed six potentially serious and unexpected adverse drug events dating back to 1999 for products that included generic Digitek, that weren’t reported to the agency.
In 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.
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 lawsuit in November.
Just last week, a the Center for Public Integrity published a report that 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.
The Food & Drug Administration (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.
A new report by the Center for Public Integrity has 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.
The Center's report faults the FDA for taking too long to act on problems at the New Jersey Actavis plant where Digitek was made. As we've previously reported, 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 New Jersey. Another FDA inspection in early 2006 revealed six potentially serious and unexpected adverse drug events dating back to 1999 for products that included generic Digitek, that weren’t reported to the agency.
The Digitek recall was issued in April 2008, and then in August, Actavis issued another recall of all generic drugs made at the New Jersey 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. After the August recall, Actavis finally closed the New Jersey plant to institute “remediation” efforts.
The problems at Actavis prompted the House of Representatives Energy and Commerce Committee to begin an investigation into the FDA's oversight of the company's drug manufacturing operations. In October, the Committee asked the FDA to provide it 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 Committee wanted 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.
In November, the US Justice Department filed suit against Actavis, seeking to permanently shut down its New Jersey operation. 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.
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."
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”.
Actavis Totowa, the maker of defective Digitek download Alamo, The 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.
In April 2008, Actavis recalled all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP, all strengths) for oral use due to a manufacturing defect. The Food & Drug Administration (FDA) said the Digitek defect could expose users to twice the amount of the active ingredient digoxin, which could cause serious and even fatal reactions. The FDA received several reports of illnesses and injuries in patients taking Digitek; Actavis said it received 11 such reports. The defective tablets contained amounts of digoxin exceeding the dose indicated on the medication’s label and, in some cases, exceeded the dose approved for medical treatment in humans.
In their suit, the Dyals claim that defective Digitek pills caused Bobbie Dyal to suffer permanent heart damage attributed to digitalis toxicity, a lethal reaction to digoxin overdose. The suit states that Bobbie Dyal began having symptoms March 21 and was later flown by helicopter to Trinity Hospital, where she remained for nearly two months, until May 5. Bobbie Dyal underwent surgery to receive a pacemaker, according to the suit. Also according to the suit, Bobbie Dyal's injury occurred a few weeks before the FDA announced the national recall.
Digitek was manufactured by Actavis Towtowa and sold by Mylan Pharmaceuticals Inc., under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label. Digitek is a form of digitalis, a chemical derived from the foxglove plant that has been used as a heart medicine since the 18th century. Several companies sell the medication generically as digoxin.
Digitalis medicines strengthen the force of the heartbeat by increasing the amount of calcium in the heart's cells. When the medicine reaches the heart muscle, it binds to sodium and potassium receptors. These receptors control the amount of calcium in the heart muscle by stopping the calcium from leaving the cells. As calcium builds up in the cells, it causes a stronger heartbeat. Digitalis medicines also control irregular heart rhythms (called arrhythmias) by slowing the signals that start in the sinoatrial (SA) node. This, in turn, reduces the number of signals that travel through the atrioventricular (AV node). Fewer signals mean fewer arrhythmias.
Actavis recalled its Digitek tablets because there existed a possibility that tablets with double the appropriate thickness might have been commercially released. The FDA deemed the Digitek recall a Class I recall, meaning that the defective Digitek tables 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. Digitalis toxicity can cause nausea; vomiting; diarrhea; dizziness; confusion; loss of appetite; low blood pressure; cardiac instability and irregular pulse; heart palpitations; and bradycardia, a slower than normal heartbeat rate.
A Digitek class action lawsuit filed on the heels of April's Digitek recall raises serious questions about the way the defective pills were made. According to the Digitek class action lawsuit, a US plant that made some of the defective Digitek tablets was the subject of a Food & Drug Administration (FDA) warning letter in 2006.
The Digitek class action lawsuit, filed in US District Court in New Jersey, says that 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. According to the complaint, some of the faulty Digitek came out of that plant. The Digitek lawsuit also claims that another FDA inspection in early 2006 revealed six potentially serious and unexpected adverse drug events dating back to 1999 for products that included generic Digitek, that weren’t reported to the agency.
The lawsuit was filed just weeks after Actavis Towtowa 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 recall involved all lots of Bertek and UDL Laboratories Digitek (digoxin tablets, USP, all strengths) for oral use. Actavis Totowa, LLC is a United States manufacturing division of the international generic pharmaceutical company Actavis Group. Actavis manufactures the products for Mylan Laboratories, which are distributed by Mylan and UDL under the Bertek and UDL labels.
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. 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 Digitek lawsuit names Actavis, Mylan and UDL as defendants. At least one of the plaintiffs in the Digitek class action lawsuit alleges she experienced “changed cardiac symptom episodes of nausea, and dizziness” from her Digitek consumption. Another plaintiff alleges he may have suffered serious personal injuries, including kidney damage, after taking the defective drug.
Digitek is a form of digitalis, a chemical derived from the foxglove plant that has been used as a heart medicine since the 18th century. The medication is sold generically as digoxin by several companies. On April 25, 2008, Actavis recalled Digitek tablets because there existed a possibility that tablets with double the appropriate thickness may have been commercially released. The Food & Drug Administration (FDA) deemed the Digitek recall a Class I recall, meaning that the defective Digitek tables 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. Digitalis toxicity can cause nausea, vomiting, diarrhea, dizziness, confusion, loss of appetite, low blood pressure, cardiac instability and irregular pulse, heart palpitations, and bradycardia.
There has been very little information available about the scope of the Digitek problems. When it announced the recall, the FDA said it had received several reports of illnesses and injuries in patient taking Digitek. Actavis said it had 11 such reports. Actavis also said it did not know how many defective batches of Digitek were actually distributed.
According to the Digitek lawsuit, 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. The suit alleges that some of the faulty generic Digitek came out of that plant. The suit also claims that an FDA inspection in early 2006 revealed six potentially serious and unexpected adverse drug events dating back to 1999 for products that included generic Digitek, that weren’t reported to the agency.
At least one of the plaintiffs in the Digitek class action lawsuit alleges she experienced “changed cardiac symptom episodes of nausea, and dizziness” from her Digitek consumption. Another plaintiff alleges he may have suffered serious personal injuries, including kidney damage, after taking the defective drug.
Actavis Totowa, LLC is a United States manufacturing division of the international generic pharmaceutical company Actavis Group. Actavis has initiated a Class 1 nationwide recall of Digitek (digoxin tablets, USP, all strengths) for oral use. The medications are distributed by Mylan Pharmaceuticals, Inc. under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label. Actavis manufactures the products for Mylan, which are distributed by Mylan and UDL under the Bertek and UDL labels; Bertek and UDL are affiliates of Mylan. Class I recalls are conducted when dangerous or defective products that predictably could cause serious health problems or death are released.
The medication Digitek is used to treat heart failure as well as abnormal heart rhythms. A double-strength tablet poses a serious risk of digitalis toxicity in those patients suffering from renal failure. Reduced kidney function will cause digitalis to accumulate in the body rather than being excreted normally through urine. When this happens, any disorders that disrupt kidney functioning—including dehydration—make digitalis toxicity more likely. Digitalis toxicity is a complication of digitalis therapy and may be caused by an acute ingestion of digitalis. Digitalis toxicity can occur from a single exposure or chronic overmedication.
Digitalis toxicity can cause nausea, vomiting, diarrhea, dizziness, confusion, loss of appetite, low blood pressure, cardiac instability and irregular pulse, heart palpitations, and bradycardia. Bradycardia is a slower than normal heartbeat rate. Vision changes such as halos or light rings around objects, seeing lights and bright colors, experiencing changes in color perception, blind spots in vision, and blurred vision can also occur. Patients can also experience decreased urine output and excessive nighttime urination, overall swelling, decreased consciousness, and difficulty breathing when lying down. At its most severe, death can result from excessive Digitalis intake. There have been several reports of illness and injuries related to the recalled medications.
Consumers can contact Stericycle’s customer service line at 1-888-276-6166. Representatives are available Monday through Friday, 8:00 am to 5:00 pm eastern standard time. Additional information about the voluntary recall can also be found at the Actavis Website at: www.actavis.us. Retailers who have this product are urged to return the product to their place of purchase. If consumers have medical questions, they should contact their health care providers. Any adverse reactions experienced with the use of this product, and/or quality problems should also be reported to the FDA's MedWatch Program by phone at 1-800-FDA-1088; by fax at 1-800-FDA-0178; by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787; or on the MedWatch Website at www.fda.gov/medwatch.