
Digitek, a medication indicated for patients with heart failure and abnormal heart rhythms, was recently recalled by its manufacturer Actavis Totowa LLC. The recall is a Class One FDA nationwide recall of Digitek® (digoxin tablets, USP, all strengths) for oral use. A Class One recall is the most serious level of recalls.
The "all lot" recall is due to the serious potential that the pills were manufactured with double the approved thickness, which may contain twice the approved level of active ingredient. As a result, the drug, in its defective form, is recognized to pose a risk of digitalis toxicity in patients. Reports of hypotension, cardiac instability, bradycardia, and death have been reported.
For more informaton, see the following:
The "all lot" recall is due to the serious potential that the pills were manufactured with double the approved thickness, which may contain twice the approved level of active ingredient. As a result, the drug, in its defective form, is recognized to pose a risk of digitalis toxicity in patients. Reports of hypotension, cardiac instability, bradycardia, and death have been reported.
For more informaton, see the following:
- FDA Notice
- Activis Consumer Question/ Answer:
- Web MD:
The Lyon Firm is investigating these cases on a local and national basis.