On April 8, 2008, the FDA announced a nationwide recall of all lots of Bertek and UDL Laboratories Digitek Tablets manufactured and distributed by generic drug-maker Actavis and Mylan Pharmaceuticals.
Digitek is a generic brand of the drug digoxin, used to treat abnormal heart rhythms and congestive heart failure.
As a result of manufacturing defects, these tablets may contain up to twice the labeled dose of the drug. If ingested, the unsafe dosages of digoxin could pose a serious risk and lead to a deadly illness called digitalis toxicity. This condition is particularly hazardous to patients with severe kidney problems.
The recall may involve Digitek Tablets manufactured as early as 2006.
Digitalis toxicity is a potentially lethal illness that is common among people with kidney troubles, especially those with renal failure. Symptoms of digitalis toxicity include nausea, vomiting, diarrhea, dizziness, confusion, loss of appetite, low blood pressure, cardiac instability and irregular pulse, heart palpations, and bradycardia (slower than normal heartbeat rate). Vision changes such as seeing lights and bright colors, experiencing changes in color perception, and blurred vision can also occur. Consumers also experience decreased urine output and excessive nighttime urination, decreased consciousness, overall swelling, and difficulty breathing while lying down.
Do not change medications without first consulting your doctor.
Name (Stock Symbol)
Actavis Totowa LLC
Actavis Totowa LLC is the United States manufacturing division of the generic pharmaceutical company Actavis Group.
Actavis manufactures generic drugs. Activis is on of the top five generic drug manufacturers by volume in the world. Actavis has 11,000 employees operating in 40 countries.
Mylan Pharmaceuticals Inc.
Mylan Pharmaceuticals Inc., a subsidiary of Mylan Inc., manufacturers generic drugs.
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