June 6, 2011 – SimplyThick thickening gel products have been recalled nationwide due to the potential for harmful bacterial contamination. The action was announced after federal investigators discovered that products manufactured at a Georgia facility did not have proper sterile operating processes in place. The new recall comes just days after the FDA issued a public health warning linking SimplyThick to an increased risk of necrotizing enterocolitis (NEC) in infants.
What’s the problem?
The SimplyThick recall was issued on June 4, 2011, after a routine FDA inspection of Thermo Pac, LLC’s Stone Mountain, Georgia manufacturing facility discovered processing operations that were not adequate to prevent dangerous bacterial contamination. SimplyThick, LLC was required to file a scheduled process with the FDA to ensure that procedures were up to par, but failed to do so. According to the company’s website,
“The SimplyThick® thickening gel products manufactured at the Thermo Pac, LLC Stone Mountain plant are being recalled because the U.S. Food and Drug Administration (FDA) advised the company that Thermo Pac, LLC failed to file with the FDA a scheduled process designed to ensure that vegetative cells (harmful bacteria) of possible public health significance are destroyed during the manufacturing process. This failure was discovered during an FDA inspection of the Thermo Pac, LLC Stone Mountain plant conducted from May 23 through June 3, 2011.”
Specific products involved in this recall include:
- all 15g and 30g pouches;
- 120g and 240g pouches that have a ‘TP’ in the lot code stamped into the edge of the packet;
- all SimplyThick pouches with item numbers 01001, 01005, 01007, 02001, 02005 and 02007;
- any SimplyThick pouches with item numbers 01004, 02004, 01006, and 02006 that have “TP” in the lot code stamped into the edge of the packet.
SimplyThick, LLC recommends that anyone in possession of SimplyThick products discard them immediately or contact the company for a full refund.
SimplyThick Necrotizing Enterocolitis (NEC)
On May 4, 2011, the FDA issued a SimplyThick public health warning stating that the products should not be given to premature infants due to the risk of necrotizing enterocolitis (NEC) that has resulted in the death of at least two infants. NEC is a catastrophic medical condition found almost exclusively in infants that is characterized by tissue death (necrosis) of the bowels. Signs and symptoms may progress rapidly and include:
- feeding intolerance
- increased gastric residuals
- abdominal distention
- bloody stools
- bloated stomach
- greenish-tinged vomiting
NEC is one of the most common GI medical emergencies reported in neonates, affecting close to 10 percent of infants weighing less than three pounds. Depending on the severity of the condition, necrotizing enterocolitis can have a mortality rate of 50 percent or more. Despite intensive study over the past 30 years, NEC’s etiology remains largely a mystery to the medical community.