Vitaflo Renastart Recall
| Date: | January 30, 2012 |
| What: | Renastart |
| Why: | Mislabled |
| Scope: | Nationwide |
Vitaflo USA announced a recall of 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 was 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.
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 and as a precautionary measure has issued this immediate recall.
Vitaflo USA is urging anyone who has any Renastart 14.11 oz. (400g) cans Batch Number 12832 to immediately stop using the product and contact Vitaflo to arrange return of the product at Vitaflo’s expense. All patients who consumed any Renastart from this batch should contact their health care professional immediately to determine next steps, including nutritional management alternatives.
Renastart 14.11 oz. (400g) product in cans is sold only in the United States. This product is not sold under any other name.
Anyone who has Vitaflo’s Renastart 14.11 oz. (400g) cans Batch Number 12832 is urged to contact Vitaflo at 1-888-848-2356. Vitaflo extended its hours of availability through this toll-free number to 24 hours a day, seven days a week to answer any questions health care professionals and patients may have in addressing this situation. Patients should always contact their health care professional.
Consumers with questions about food safety can Ask Heidi, a certified food safety professional.
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