AS Medications Solution LLC. Announces a Nationwide Recall of All Lots of Digoxin Tablets 0.25mg Due to Size Variability

A S Medication Solutions, LLC, a drug repackage company, announced today that all tablets of Caraco brand Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of August, 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. Caraco Pharmaceutical Laboratories, Ltd manufactured the recalled tablets. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Digoxin is a drug product used to treat heart failure and abnormal heart rhythms. It has a narrow therapeutic index and the existence of 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 slow heart rate. Death can also result from excessive digoxin intake. A lower than labeled dose may pose a risk of heart failure and abnormal heart rhythms.. Consequently, as a precautionary measure, A S Medication Solutions, LLC is recalling these tablets to the consumer level to minimize any potential risk to patients.

Consumers with the products with the following NDC codes that are within expiration should return these products to the place of purchase.

Product Identification

Caraco Digoxin
A-S Medication Solutions, Digoxin 0.25 mg is a scored round biconvex white tablet imprinted with “441”

NDC Numbers:
Digoxin Tablets, USP, 0.25 mg
54569-5758-0 (30-count)

Patients using A-S Medication Solutions, Digoxin tablets, USP, 0.25 mg, who have medical questions should contact their healthcare provider for additional instructions or guidance.

Healthcare providers who have this product should return the product to their place of purchase. Healthcare providers can call A-S Medication Solutions Recall Coordinator at (847) 680-3515, Monday through Friday, 8:00 a.m. – 4:00 p.m. CST, 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, and/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, or on the MedWatch website at www.fda.gov/medwatch.

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New Biomarker for Heart Failure Identified

Blood levels of resistin, a hormone produced by fat cells, can independently predict an individual¿s risk of heart failure, cardiologists at Emory University School of Medicine have found.

Their findings were presented Nov. 12 at the American Heart Association Scientific Sessions conference in New Orleans.

"This is one of the strongest predictors of new-onset heart failure we've been able to find, and it holds up even when you control for other biomarkers and risk factors including high blood pressure and diabetes," says Javed Butler, MD, MPH, associate professor of medicine and director of heart failure research at Emory University School of Medicine.

The finding comes out of the Health ABC (Aging and Body Composition) study, sponsored by the National Institute on Aging of the National Institutes of Health. The Health ABC study followed 3000 elderly people in the Pittsburgh and Memphis areas over seven years starting in 1998.

Although scientists don't know the exact function of resistin, it appears to be associated with both inflammation and insulin resistance, says Vasiliki Georgiopoulou, MD, a post-doctoral research fellow with Butler who presented these findings. "Recent laboratory studies have also shown that resistin decreases the ability of rats¿ heart muscles to contract," she adds.

In the Health ABC study, the risk of new onset heart failure increased by 38 percent for every 10 nanograms per milliliter increase in resistin levels in blood. Resistin was a stronger predictor of heart failure risk than other inflammatory markers linked to heart disease, such as C-reactive protein, the researchers found.

"Considering the increasing number of people who are obese or have diabetes, very many of them are going to be at some level of risk for heart failure later in life," Butler says. "The value of a marker such as resistin may be in accurately identifying among this large population of at-risk individuals who is at the highest risk and then targeting interventions to those people."

Investigators from several institutions contributed to the study, including the University of Lausanne, Harvard Medical School, University of California San Francisco, University of Pittsburgh, Wake Forest University, Boston University and the National Institute on Aging.

About Emory Heart & Vascular Center Emory Heart & Vascular Center doctors are committed to providing clinically excellent cardiovascular patient care, pioneering innovative clinical research and training the best heart specialists in the world. A component of Emory Healthcare, the Center is consistently recognized by U.S. News & World Report as one of the top heart centers in the country. Emory Healthcare is the clinical arm of Emory University's Woodruff Health Sciences Center and is the largest, most comprehensive health care system in Georgia.

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