Mislabeled Renastart Pediatric Formula Recalled

Vitaflo USA just initiated a recall of its Renastart pediatric powdered medical food, the U.S. Food and Drug Administration (FDA) just announced.

The recalled Renastart is packaged in 14.11 oz (400g) cans and bears Batch Number 12832, which appears on the underside of can. The recall was initiated because some of the Renastart product that was shipped throughout the United States from December 29, 2011 through January 26, 2012 was incorrectly labeled.

Renastart is used in the dietary management of pediatric renal disease and is typically prescribed for patients who are one year of age 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 by this recall.

Although, to date, no cases of illness or other adverse effects have been reported to Vitaflo USA, 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.

Use of the incorrectly labeled Renastart 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 that can potentially lead to death, which is why involvement with a health care professional is critical.

Longer-term consequences can result in increased levels of calcium, phosphorus, and protein.

Following a customer complaint regarding the way in which 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 the matter and urges 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.

Vitaflo USA said it has directly advised renal centers and health care providers to immediately stop using the recalled product and patients are being asked to contact their health care professional. Vitaflo’s Clinical Science Liaison is available to answer questions health care professionals may have in addressing their patients’ needs.

Vitaflo can be reached, toll-free, at 1.888.848.2356 and has extended its hours of availability through this toll-free number to 24 hours a day, seven days a week to answer health care professional and patient questions concerning this recall. Vitaflo’s web site can be accessed at www.vitaflousa.com.

This entry was posted in Product Recalls. Bookmark the permalink.

© 2005-2019 Parker Waichman LLP ®. All Rights Reserved.