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.