Renastart by Vitaflo USA Recall for Wrong Container Labels, Potential Health Risks

Consumers, pediatrics and medical professionals have been alerted by the FDA of the voluntary recall instigated by Vitaflo USA for their product, Renastart, which was found to have some cases of wrongly labeled containers.

Background of Vitaflo’s Renastart

The product Renastart, manufactured by Vitaflo USA, is a supplementary medical foodstuff in powder form. It is used to manage and provide for the dietary needs in pediatric patients suffering from renal disease.

The availability and distribution of Vitaflo’s Renastart powdered food is limited to the United States. Renastart is packaged in 400-gram containers of 14.11 ounces and is recommended for patients aged 1 year and above.

FDA Alert

The recall of Renastart pediatric food supplement was initiated on a voluntary basis by the manufacturer, Vitaflo USA.

Details of the affected product lots in the recall are as follows:

Product Recalled: Renastart

Package Quantity: 400 g. ( 14.11 oz.)

Recalled Batch No.: 12832

Distribution Period: 29^th Dec, 2011 to 26^th Jan, 2012

Other products by the same manufacturer were however not affected, and that includes other Renastart product lots other than those within the Batch 12832 line, as well as Renastart satchets which were not included in the recall.

Issues associated with the recall were mainly:

• Incorrect labels on the product container
• Potential medical risks due to mislabeled packaging

The above issues were established after reports of a case where the product was seen to dissolve in a strange way only for the problem to be identified as wrong product labeling.

Some of the health risks that culminate from the use of improperly labeled cans of Renastart include:

• Hyperkalemia – high levels of Potassium in the bloodstream
• Hypernatremia – high levels of Sodium in the bloodstream

FDA Recommendation

“ Vitaflo USA is urging anyone who has any Renastart 14.11 oz (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. ”

Contacting the FDA to report cases relating to Vitaflo’s Renastart

• Any adverse side effects or incidences relating to the use of Renastart from Vitaflo USA should immediately be reported to the FDA.
• This should be done by contacting or informing the FDA’s MedWatch Safety Information & Adverse Event Reporting Program through any of the following ways:
• Filling and submitting an online report at: http://www.fda.gov/MedWatch/report.htm
• Download the case reporting form at:http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm
• Dialing 1-800-332-1088 and requesting to get a report form, filling it and returning it to the address indicated on the form
• Faxing the filled-up form to the fax number: 1-800-FDA-0178

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