Digitek (Digoxin Tablets)

Approved: 12/23/1999 to treat heart failure (congestive) and abnormal heart rhythms.

Manufactured by Actavis Totowa LLC, a United States manufacturing division of the international generic pharmaceutical company Actavis Group. Distributed by Mylan Pharmaceuticals Inc. under a "Bertek" label and by UDL Laboratories, Inc. under a "UDL" label. Actavis manufactures the products for Mylan and the products are distributed by Mylan and UDL under the Bertek and UDL labels. Bertek and UDL are affiliates of Mylan. Actavis manufactures approximately half of the digoxin sold in the United States.

Recalled: 4/28/2008. A class I nationwide recall due to manufacturing defects which caused some of the digoxin tablets to contain double the appropriate amount of active ingredients, possibly resulting in Digitalis Toxicity, a serious and potentially fatal illness which is known to occur in people with impaired kidney function, particularly those with renal failure. Reduced kidney function will cause digitalis to accumulate in the body rather than being excreted normally through urine. Any disorders that disrupt kidney functioning (including dehydration) make digitalis toxicity more likely.

Digitalis Toxicity may cause unusual visual changes (blurred vision, blind spots, changes in color perception, seeing lights or bright spots, halos or rings of light around objects), confusion, loss of appetite, anorexia, nausea, vomiting, diarrhea, palpitations, irregular pulse, low blood pressure, cardiac instability, bradycardia, potentially lethal arrhythmias, and heart failure. Additional symptoms that may be associated with digitalis toxicity include decreased urine output, excessive nighttime urination, overall swelling, decreased consciousness and difficulty breathing when lying down. Reports suggest that the defective Digitek tablets may have been sold for over a year.

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Additional Information: Digitek FDA Recall

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