On April 25, 2008, a recall was issued for all Digitek tablets distributed by Mylan Pharmaceuticals and sold under the labels “Bertek” and “UDL.” According to Digitek’s maker, a manufacturing defect may have caused double-strength Digitek tablets to be released to the public. Consequently, the nationwide recall was voluntarily issued as a precautionary measure.

Although very little information is available about the scope of the Digitek problems, the Digitek recall is classified as a class I recall. This is the most serious recall classification that can be issued. As defined by the Food and Drug Administration (“FDA”), a class I recall is “a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.”

Digitek Recall & Digitalis Toxicity

Digitek, which contains the active ingredient digoxin, is used to treat heart

failure and abnormal heart rhythms. In order to be effective, Digitek must be given in high doses, and as a result, standard Digitek pills are potent. In fact, standard Digitek pills are only slightly weaker than a dose likely to cause serious side effects.

Because standard Digitek pills are almost powerful enough to cause serious side effects, the recalled double-strength Digitek pills may be extremely dangerous. In fact, recall information posted on the FDA website states that the recalled double-strength Digitek pills pose a risk of digitalis toxicity, a potentially fatal condition caused by Digitek overdose. Side effects associated with digitalis toxicity include:

  • nausea
  • vomiting
  • dizziness
  • low blood pressure
  • cardiac instability
  • slow heart rate
  • death

Digitek Recall Litigation

Following the April 25, 2008 Digitek recall, a class action lawsuit was filed against Digitek’s maker, Actavis Totowa LLC. The plaintiffs in the Digitek lawsuit are seeking compensation for their injuries, as well as the costs of medical monitoring in case they experience future health problems. In addition to Actavis Totowa LLC, the Digitek lawsuit also names Mylan Pharmaceuticals Inc. and UDL Laboratories, companies that distributed the defective Digitek, as defendants.

If you or a family member took the recalled Digitek tablets and experienced a serious side effect, please contact us today to assess your legal rights.

Published November 17, 2011 by