08222017Headline:

Charlottesville, Virginia

HomeVirginiaCharlottesville

Email Greg Webb Greg Webb on LinkedIn Greg Webb on Facebook
Greg Webb
Greg Webb
Attorney • (800) 451-1288

FDA Warns About Simply Thick® Baby Formula Agent and Re-Issues Recall

Comments Off

Parents and caregivers may remember that in May 2011 the FDA recalled Simply Thick®, a thickening gel agent to be added to breast milk and baby formula with the goal of helping especially premature babies swallow their food and keep it down. The products manufactured at Thermo Pac LLC’s Stone Mountain, Georgia, plant were recalled by the FDA due to the suspected presence of harmful bacteria (vegetative cells) in the thickening gel processed at the Stone Mountain plant. All 15 and 30 gram pouches of the product and 120 gram and 240 gram pouches which had a “TP” in the lot code stamped on the product were recalled at that time.

On May 20, 2011, the company notified customers and medical professionals in the U.S. and Canada not to give the product to premature babies, to infants born before 37 weeks gestation who are currently receiving hospital care or who had been discharged from the hospital within 30 days (of the announcement), pending the results of the company’s, the FDA’s and the Canadian Food Service Inspection Agency’s (CFIA’s) investigations. On June 4, 2011, the FDA issued a voluntary recall of the products manufactured at the Stone Mountain, Georgia, plant since 2009.

September 18, 2012, the FDA, expanded their warning to parents and caregivers regarding using Simply Thick for “infants of any age”. According to the FDA’s current warning notice, “Since May 2011, the agency has identified 22 infants who developed necrotizing enterocolitis (NEC), a condition in which tissue in the intestines becomes inflamed and dies, after being fed SimplyThick. Seven of those infants died.”

The FDA noted that additional study would be required “to determine if there is an actual link between consumption of SimplyThick and the development of NEC.” In the meantime, FDA wants everyone involved in the care of a baby to be aware of the potential risk before feeding SimplyThick to infants of any age.