The following is a Digitek timeline of events following Digitek from 1992 to its recall in April, 2008
February 1992 through September 2002, Charles Cullen, a former nurse and the most prolific serial killer in New Jersey history murders as many as 45 patients in 10 hospitals in New jersey and Pennsylvania. Digitek overdose was responsible for the cause of death in at least 17 patients.
January through February 2006, a Food and Drug Administration (FDA) review of Actavis, finds potentially serious and unexpected adverse drug experiences” dating back to 1999 for several products, including Digitek (digoxin), that were not reported to the FDA.
On August 15, 2006, The Food and Drug Administration (FDA) notified the drug’s manufacturer, Actavis, in a warning letter dated August 15, 2006, of its failure to file periodic safety reports at its New Jersey facility. This failure violated Actavis’ adverse medical event reporting obligations, resulting in drugs being marketed without proper clearance and causing at least 26 adverse drug experiences.
On April 25, 2008, Actavis Totowa, LLC issued a Class I recall of Digitek (digoxin) tablets. Digitek was recalled due to the possibility that tablets were doubled in thickness and could contain twice the appropriate level of the active ingredient.
On May 1, 2008, a Newsday.com article, “Pharmacists will call you: Digitek recalled,” suggests that the defective Digitek tablets may have been sold for more than a year before the recall. Actavis counsel John LaRocca is quoted as saying that Actavis had some concerns about the process and recalled Digitek after at least one pill emerged from the manufacturing process at double the appropriate thickness
Do you have a Digitek claim?
If you or your loved one has suffered a serious injury or death as a result of Digitek, you may be entitled to compensation for medical expenses, loss of wages, and pain and suffering.
Please contact our Digitek lawyers today by filling out the brief questionnaire, or by calling our toll free number (1-800-898-2034) for a free, no-cost, no-obligation legal evaluation of your case.