Actavis Totowa issued a press release (found here on the FDA website and discussed here on US Recall News) announcing a “precautionary, voluntary recall” of all drug products manufactured at its Little Falls, New Jersey facility.
Back in May US Recall News uncovered an FDA report released in the summer of 2006 that outlines some of the FDA’s findings on the substandard quality control processes and procedures at the Actavis Totowa facility in Little Falls, New Jersey. However, it was only after a major drug recall (Digitek) and a subsequent inspection by the FDA earlier this year (with similar findings) that Actavis Totowa did the right thing by voluntarily recalling ALL pharmaceutical drug products made at their New Jersey location.
Some of the drugs produced at this facility can cause fatal results if taken at higher-than-prescribed doses. For instance, the New Jersey Actavis Totowa plant made Digoxin, Oxycodone, Hydrocodone, Phentermine and Tizanidine, among other potentially dangerous drugs. Oxycodone (also known by another brand name not involved in this recall: Oxycontin) is a very powerful pain killer and the subject of heated debates over deaths related to its widespread abuse. Hydrocodone is also a highly addictive prescription pain killer. Tizanidine is an addictive muscle relaxer associated with hypotension (low blood pressure) and liver toxicity. Digoxin is the subject of current wrongful death lawsuits, and was the drug of choice in a series of murders in the 1980’s and 90’s.
With such potentially dangerous drugs being produced, one would think the 2006 FDA report stating that “Prompt action to correct all of the deficiencies” must be taken, and that “Failure to promptly correct these deviations may result in regulatory action without further notice” would have yielded these results within a time frame much shorter than two full years. Instead, it took a second FDA inspection earlier this year and hundreds of potential lawsuits, for these products to finally be recalled. One could say “better late than never” but I wouldn’t do it in front of any of these people.
Complaints against Actavis Totowa are already being filed in Federal Court regarding the Digitek recall (see excerpt of one such complaint below). We will have to wait and see if similar complaints are made regarding any of these other drugs – although no evidence (other than being made in the same facility) yet supports the presumption that these pills were double-strength like the Digitek (digoxin) tablets.
An excerpt from a complaint and jury demand made by Colorado law firm Klein Frank, P.C. on behalf of one of their clients:
This is a wrongful death action for the death of Plaintiff’s Decedent… on August 18, 2007, that was directly and proximately caused by the Defendants’ negligent and wrongful conduct in connection with the inadequate designing, manufacturing, producing, supplying, inspecting, testing, selling and distributing dangerous, defective, misbranded and adulterated digoxin tablets known as Digitek which contained amount of the drug’s active ingredient, digoxin, exceeding the dose set forth on the label and in some cases exceeding the dose approved for medical treatment in humans.
Defendants knew or should have known that they designed, developed, manufactured, produced, processed, compounded, formulated, tested, sold, marketed, labeled, packaged, dosed, advertised, promoted, supplied, released and/or distributed Digitek with excessive unapproved amounts of digoxin before any of the Recalled Digitek was released for distribution and sale and, they mislabeled the Recalled Digitek.
Does anyone know of any class actions suits against this company for the issue with the OXYCODONE, been on it for a while, couldnt get it, went into severe withdrawals which led to a visit to the ER and more than a week and a half of hell. Not even taking Dilaudid helped, as the crapper become my best friend and the stomach pain and spasms were brutal! Now facing the other issues/symptoms but have made the decision after getting past the detox that this stuff is poison to me and trying to go clean and live with pain right now.
My prayers are with all of you have have suffered loss or are enduring more difficulty due to these poorly manufactured medicines. SPREAD THE WORD: “THE STATUTE OF LIMITATIONS PUNISHES PATIENTS AND PROTECTS THE MEDICAL INDUSTRY AND IS TOTALLY UNCONSTITUTIONAL AND NEEDS TO BE REPEALED!” What happened to ensure the general welfare and securing the blessings of liberty???
i think oxycodone shouldnt be outlawed , if so people will use dirty needles to get the wrong pain drugs …serious probs than ..heroin will be up and our gov will go back to the drug war of fighting ….south america and china and north korea plus mexico damn tylenol straight tylenol over the counter can kill you its not the drug seriously its the people mostly …from steve in ca .people need oxycontin for fibromyalgia and cancer and spinal stenosis ,,,so there you go it cuts bothways
Gabriel grady says
Oxycontin is a designer drug with all it intentions to getting the user strung. The makers could put additives which would make oxy’s impossible to snort slam or smoke so f oxys the insurance companies are turng us into junkies! Stop n think i bet 80% of this country on some form of opiate so stop the junk before our childern are smoking oxi 80s behind every middle school around!!!! Oxicontin ruined my mind and i fight every day to keep the urge away and its everywhere idk someone put that gel stuff in oxucontin and alot of misuse will end i hope anyway!!!