Digitek Recall

On April 25, 2008, a recall was issued for all Digitek tablets distributed by Digitek Mylan Pharmaceuticals and sold under the labels "Bertek" and "UDL." According to DigitekтАЩs 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 FDA, a class I recall is тАЬa 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.тА?

Digitek Recall & Digitalis Toxicity
Digitek, which contains the active ingredient digoxin, is used to treat heart

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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 DigitekтАЩs 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, 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.

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