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A Digitek recall was announced in April 2008. This Class I, nationwide recall was of all lots and all dosage levels of the Digitek tablets distributed by:

• Mylan Pharmaceuticals, under the label “Bertek”
• UDL Laboratories, under the label “UDL”

If you have a prescription for Digitek, it’s a good idea to check whether the medicine’s label shows "Bertek Digitek" or "UDL Digitek.” These are the recalled drugs, and they’re in oral tablet form.

The April 2008 Digitek recall was considered Class I by the FDA. Class I recalls are issued when there is “a reasonable probability that the use of or exposure to the product will cause serious adverse health consequences or death.”

Reason for the April 2008 Digitek Recall

The Digitek recall in April 2008 was initiated by the manufacturer, Actavis Totowa LLC, a U.S. manufacturing division of the international pharmaceutical company Actavis Group. The recall was based on the risk of toxicity from a manufacturing mistake. Some of the recalled Digitek tablets may have twice the level of active ingredient, digitalis.

FDA Safety Alert

Digitalis has profound effects on the heart. When used correctly, it is effective and beneficial. In an overdose, it can be fatal. The FDA posted a Safety Alert in April 2008 to family physicians, cardiologists, pharmacists, other healthcare professionals, and patients regarding the Digitek recall, noting that several cases of illnesses and injuries related to Digitek had been reported.

The double-dose Digitek is especially dangerous to patients with any level of renal (kidney) impairment.

Potentially Fatal Digitek Side Effects

Although Digitek is used to treat heart problems such as irregular heart beat and heart failure, an excess intake can result in very severe Digitek side effects, including:

• nausea
• vomiting
• dizziness
• low blood pressure
• cardiac instability
• bradycardia (abnormally slow heart beat)

Sometimes Digitek side effects can be fatal.

Learn More about the Digitek Recall

If you are concerned about the Digitek recall or have suffered a severe Digitek side effect, contact an experienced Digitek Lawyer today. A class action lawsuit has been initiated regarding this dangerous drug.