(dailyRx)

Caraco Pharmaceutical Laboratories, Ltd., a generic pharmaceutical company, has announced all tablets of Caraco-brand digoxin, USP, 0.125 mg and digoxin, USP, 0.25 mg distributed prior to March 31, 2009, that are not expired and are within the expiration date of September, 2011, are being voluntarily recalled to the consumer level.

The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin. The recalled tablets were manufactured by Caraco Pharmaceutical Laboratories, Ltd. This recall is being conducted with the knowledge of the FDA.

Digoxin is used to treat heart failure and abnormal heart rhythms. It has a narrow therapeutic index, and 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.

Consumers with the products with the following NDC codes within expiration should return these products to their pharmacy or place of purchase:

  • Digoxin tablets, USP, 0.125 mg
    • 57664-437-88 (100-count)
    • 57664-437-18 (1,000-count)
  • Digoxin tablets, USP, 0.25 mg
    • 57664-441-88 (100-count)
    • 57664-441-18 (1,000-count)

Patients using Caraco's digoxin tablets, USP, 0.125 mg or 0.25 mg who have medical questions should contact their health care provider for additional instructions or guidance.

Retailers who have this product should return the product to their place of purchase. Retailers can call Caraco customer service at 800-818-4555, Monday through Friday, 8:00 a.m. to 5:00 p.m. EST, for instructions on how to return the affected product or for any other inquiries related to this action.

Any adverse reactions experienced with the use of all affected product or quality problems should also be reported to the FDA's MedWatch Program:

  • By phone at 1-800-FDA-1088
  • By fax at 1-800-FDA-0178
  • By mail at Med Watch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
  • Online at www.fda.gov/medwatch

Contact:
Daniel Movens
313-871-8400