FYI. Please pass this along to others, where appropriate.
Shona R. Whitehead
Program Coordinator
Heartland Genetics and Newborn Screening Collaborative
405-271-8001 ext. 42190
From: Matthew Tranter [mailto:[log in to unmask]]
Sent: Thursday, February 09, 2012 2:13 PM
Subject: FDA Alert regarding Vitaflo USA Renastart
Good Afternoon Rcs -
The FDA Alert regarding Vitaflo USA Renastart (below) was brought to the attention of ACMG by Katherine Harris, Project Manager, NYMAC, and is being disseminated to the other Regional Collaboratives as an FYI item, in case the alert was not received from FDA by your RC. Please make the alert available to your contacts, as you deem appropriate.
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Vitaflo USA Renastart: Recall - Possible Health Risk Due To Incorrectly Labeled Cans
AUDIENCE: Pediatrics, Health Professionals, Consumers
ISSUE: Vitaflo USA has announced a voluntary recall of Renastart 14.11 oz (400g) cans, Batch Number 12832, because some of the product shipped throughout the United States during the period December 29, 2011 through January 26, 2012 was incorrectly labeled. 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). All other Vitaflo products, including Renastart cans in batches other than 12832 and Renastart packed in sachets, are not affected.
BACKGROUND: Renastart is a powdered medical food used in the dietary management of pediatric renal disease, for patients one year and older. Renastart 14.11oz (400g) product in cans is sold only in the United States. 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.
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.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
Read the MedWatch safety alert, including a link to the Press Release, at:
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm289705.htm
You are encouraged to report all serious adverse events and product quality problems to FDA MedWatch at www.fda.gov/medwatch/report.htm
Matthew Tranter
Project Assistant
National Coordinating Center for the
Regional Genetic & Newborn Screening Collaboratives
7220 Wisconsin Ave.
Suite 300
Bethesda, MD 20814
T: 301-718-9603
F: 301-718-9604