Generic pharmaceutical maker Caraco Pharmacuetical Labratories has announced a nationwide recall of Caraco brand Digoxin tablets for possible overdose risks. The recall includes all Caraco brand Digoxin tablets (USP, .125mg & USP, .25mg) distributed before March 31,2009, that have not expired, and have an expiration date of before September of 2011.
The tablets are being recalled because the tablets may differ in size; therefore, may contain inadequate or excessive amounts of the active ingredient digoxin.
Digoxin is used to treat heart failure and abnormal heart rhythms. An overdose of digoxin can result in digoxin toxicity which can pose a significant health threat to individuals taking the medication.
Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability. Consequently, as a precautionary measure, Caraco is recalling these tablets to the consumer level to minimize any potential risk to patients.
Consumers in possession of recalled batches of digoxin should immediately discontinue use of the tablets and contact their pharmacist for additional instructions.
For more information please see the FDA’s Digoxin Recall Press Release.