January 31, 2012
RECALL: Renastart Medical Food Cans Incorrectly LabeledVitaflo USA and the FDA have announced a voluntary recall of Renastart, a powdered medical food, because some of the products are incorrectly labeled. The recall affects 14.11oz. (400g) cans of Renastart from Batch #12832, distributed from December 29, 2011 through January 26, 2012. 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 improperly labeled as Renastart.
Healthcare professionals and patients who have the affected product in their possession should stop using it immediately. Patients are advised to contact their healthcare provider if any adverse effects related to use of the product occur.
Renastart is used in the dietary management of pediatric renal disease for patients ≥1 year old.
For more information, call (888) 848-2356 or visit www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm289705.htm.