The recalled products are 0.125 mg and 0.25 mg of Caraco Digoxin Tablets, USP, distributed before March 31, 2009, which are within the expiration date of September 2011.
Adverse events: Tablets with a higher dose of the drug than printed on the label may be toxic to people who take the product and who have kidney failure. Taking too much of the drug can cause nausea, vomiting, dizziness, low blood pressure, abnormal heartbeat, and even death. Tablets with a lower dose of the drug than printed on the label may not be effective and could cause abnormal heartbeat.
People at risk: Anyone who has taken the recalled Caraco brand of digoxin tablets.
You can identify the recalled products by appearance:
- Caraco Digoxin, USP, 0.125 mg is a yellow round-shaped tablet with a cut mark (score) in the middle on one side and the imprinted number "437" on the other side.
- Caraco Digoxin, USP, 0.25 mg is a white round-shaped tablet scored in the middle on one side and imprinted with "441" on the other side.
Recommendations:
- Stop taking the recalled product and return it to your pharmacy or place of purchase.
- Contact your health care professional if you have questions.
For more information:
Manufacturer's Press Release - www.fda.gov/oc/po/firmrecalls/caraco03_09.html
