Last week, the Food and Drug Administration announced the voluntary recall by VitafloUSA of a powdered medical food labeled as Renastart, due to a possible health risk. Renastart is used in the dietary management of pediatric renal disease, for patients one year and older in the United States. Renastart's Batch 12832 was incorrectly labeled and was shipped throughout the U.S. during from December 29, 2011, through January 26, 2012.　According to VitafloUSA, all other Vitaflo products, including Renastart cans in batches other than 12832 and Renastart packed in sachets, are not affected.

Although no cases of illness have been reported at this time, some immediate consequences of using the erroneously labeled product could result in high potassium blood levels (hyperkalemia) or high sodium levels in the blood (hypernatremia). And although the symptoms may be hard for an individual to detect, they can result in significant health consequences potentially leading to death. If parents, caregivers or health care providers are aware that a patient may have consumed any of this batch of Renastart, please have the responsible parties contact the patient's primary care physician immediately. Longer term consequences can result in increased levels of calcium, phosphorus, and protein.

PR Newswire published the following on their website: "All patients who have consumed any Renastart from this batch should contact their health care professional immediately to determine next steps, including nutritional management alternatives." http://www.prnewswire.com/news-releases/vitaflo-usa-announces-nationwide-voluntary-recall-of-renastart-1411-oz-400g-cans-batch-number-12832-due-to-possible-health-risk-138360064.html　

Since this is a pediatric powdered medical food, many of the patients who consume　Renastart will be children or young adults--it is important for parents of children who may be at risk to contact their child's primary care provider. While VitafloUSA believes the error may have occurred in a small number of cans, they are proceeding with the recall of the entire batch. At this time, we have no information on how many cans of the Renastart powdered medical food is involved.

Jennifer Szymanski, General Manager of Vitaflo USA, indicated that Vitaflo has communicated directly with renal centers and health care providers to immediately stop using the specific batch of product.　Vitaflo's Clinical Science Liaison is available to answer any questions that health care professionals may have in addressing the needs of their patients. The U.S. Food and Drug Administration is informed of all actions Vitaflo is taking with regard to this recall. For additional information, please contact Vitaflo by phone at 1-888-848-2356.

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