Medication Monitor



Generic Name (Trade Name—Company)
Notes
June 5, 2011

Thickening formula

(SimplyThick—SimplyThick)
Do not feed product to premature infants

FDA issued an alert that SimplyThick should not be given to premature infants because the product may cause necrotizing enterocolitis (NEC). Specifically, SimplyThick should not be given to infants born before 37 weeks' gestation who are currently receiving hospital care or have been discharged from the hospital within the past 30 days. The agency is currenlty aware of 15 cases of NEC, including two deaths, involving premature infants who were fed SimplyThick for varying amounts of time. The product was mixed with mothers’ breast milk or infant formula products.

On June 4, SimplyThick voluntarily recalled its thickening gel product manufactured at its Stone Mountain, GA, plant. SimplyThick's recall of this product is a result of the company's failure to ensure that harmful bacteria of possible public health significance were destroyed in the manufacturing process at that manufacturing plant. Product manufactured at other facilities remains on the market.