 |
 |
|
Digoxin, USP 0.125 mg and Digoxin USP 0.25 mg tablets Recalled
Update: May 12, 2009 Digoxin, USP, .25 mg Tablets Also RecalledThe FDA and Caraco Pharmaceutical Laboratories, Ltd, have additionally recalled Digoxin, USP, 0.25 mg tablets distributed prior to March 31, 2009 and with an expiration date of September 2011. This tablet is a scored round biconvex white tablet imprinted with "441" and an NDC number of 54569-5758-0 (30-count). For more information, read the complete MedWatch 2009 safety summary, which includes a link to the original April 1 alert and the current firm press release. The FDA and Caraco Pharmaceutical Laboratories are recalling Digoxin, USP 0.125 mg and Digoxin, USP 0.25 mg tablets. Digoxin is used to treat heart failure and abnormal heart rhythms. Product Description:
This recall has been issued because there may be a variation in the size of the pills, affecting the amount of active ingredients in the tablets. The existence of a higher than labeled dose may cause a harmful amount of digoxin in the body, especially in patients with renal failure. Symptoms of an overdose may include nausea, vomiting, dizziness, low blood pressure, cardiac instability and bradycardia. Excessive digoxin intake may also cause life-threatening health conditions. A lower than labeled dose may decrease the effectiveness of the drug, potentially resulting in cardiac instability. The affected tablets were distributed prior to March 31, 2009 and have the expiration date of September 2011. Patients with the recalled product should return them to their pharmacy or place of purchase immediately. Read the MedWatch safety summary, which includes a link to the company Press Release. Source: The Food and Drug Administration |
 |
 |