January 31, 2012

Vitaflo USA Recalls Renastart 14.11 oz (400g) Cans Batch Number 12832

The Missouri Department of Health and Senior Services received the following recall of Vitaflo USA's powdered medical food, Renastart.

Vitaflo USA is recalling Renastart 14.11 oz (400g) cans, Batch Number 12832 (shown on underside of can), because some because of incorrect labeling.

Renastart is a powdered medical food used in the dietary management of pediatric renal disease, for patients one year and older.

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.

Anyone who has any Renastart 14.11oz (400g) cans Batch Number 12832 should 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 full recall announcement can be found at: www.fda.gov/Safety/Recalls/ucm289658.htm?source=govdelivery.