Beasley, Allen, Crow, Methvin, Portis & Miles, P.C.

Caraco Pharmaceutical Laboratories has alerted the Food and Drug Administration (FDA) and is issuing a consumer-level recall of all tablets of the generic medication Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011. The drugs are being voluntarily recalled. The tablets may differ in size and could contain more or less of the active ingredient, digoxin.

Digoxin is a drug product used to treat heart failure and abnormal heart rhythms. A higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. 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. Caraco is recalling these tablets to the consumer level to minimize any potential risk to patients.

Last year, Actavis Totowa LLC, a generic pharmaceutical company initiated a Class 1 recall on Digitek brand digoxin tablets when it was learned that some tablets were oversized and contained twice the level of active ingredient, putting consumers at risk.

Consumers of Caraco’s digoxin tablets that fall within the recall should return these products to their pharmacy or place of purchase. Patients who have medical questions should contact their healthcare provider for additional instructions or guidance.

Source: FDA

This entry was posted on Wednesday, April 1st, 2009 at 8:35 am and is filed under Digitek Legal, Digitek recall. You can follow any responses to this entry through the RSS 2.0 feed. You can leave a response, or trackback from your own site.