The FDA released a voluntary recall notice from Vitaflo USA. Vitaflo USA is recalling Renastart 14.11 oz (400g) cans, Batch Number 12832 (shown on underside of can), because some of the product shipped throughout the United States during the period December 29, 2011 through January 26, 2012 has been incorrectly labeled. Renastart is a powdered medical food used in the dietary management of pediatric renal disease, for patients one year and older in the United States. All other Vitaflo products, including Renastart cans in batches other than 12832 and Renastart packed in sachets, are not affected in any way.
Some immediate consequences of using the incorrectly labeled product may result in high potassium blood levels (hyperkalemia) or high sodium levels in the blood (hypernatremia). In most cases, symptoms may be hard for an individual to detect, but can result in significant health consequences potentially leading to death, which is the importance for contacting a health care professional. Longer term consequences can result in increased levels of calcium, phosphorus, and protein.
There have been no cases of illness or other adverse effects reported to Vitaflo USA. Following a customer complaint regarding the way the product was dissolving, Vitaflo determined that a small number of cans of a different product may have been wrongly labeled as Renastart. The company is investigating to make sure we continue to safely meet the needs of our patients and as a precautionary measure has issued this immediate voluntary recall.
Vitaflo USA is urging anyone who has any Renastart 14.11oz (400g) cans Batch Number 12832 to immediately stop using the product and to contact Vitaflo to arrange return of the product, at Vitaflo’s expense. 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.
The Vitaflo recall emphasizes the need to properly label and monitor batch numbers. As the investigation by Vitaflo continues look for more recall information and possibly a Medical Device Report (MDR).
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