Product Recall: SimplyThick¬ģ and Premature Infants

Published on: 06/04/2011
Babies are at risk of illness or death from SimplyThick brand of thickening agent added to formula and breast milk. Shown: Label of SimplyThick product associated with necrotizing enterocolitis (NEC) in premature infants.
 

June 4, 2011 — Product Recall - Simply Thick, LLC Announces The Voluntary Recall Of Products Manufactured By Thermo Pac, LLC At Their Stone Mountain, GA Food Processing Plant. For additional information, please refer to the company issued press release available on FDA's web site at www.fda.gov/Safety/Recalls/UCM257841
 
May 23, 2011 — The Food & Drug Administration has released a Safety Alert for all parents, caregivers and health care providers advising them not to feed SimplyThick, a thickening agent for management of swallowing disorders, to infants, born before 37 weeks, who are currently in the hospital or have been discharged in the past 30 days. The product may cause necrotizing enterocolitis (NEC).   There have been reports from several hospitals nationwide of babies who were fed SimplyThick added to human milk or infant formula and developed NEC.  It is unknown at this time if Simply Thick is causing the NEC.
 
Although SimplyThick is in use at Nicklaus Children's Hospital to thicken liquids, its use was not approved for infants in the NICU. We recognize that premature infants occasionally may be admitted to units other than the NICU and thus we are advising all medical, nursing and support staff of this FDA Alert.
 
Please do not hesitate to contact me with any questions or concerns.
 
Thank you,
Erin Corrigan, MS, RD
Clinical Nutrition Manager
Ext 4523

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