In the middle of 2011, the United States Food and Drug Administration issued a warning that the product SimplyThick may be responsible for causing the dangerous condition known as necrotizing enterocolitis (NEC) if used in breast milk or formula. Shortly after issuing this announcement, the Food and Drug Administration (FDA) inspected a plant manufacturing SimplyThick in Stone Mountain, Georgia. The FDA inspection turned up numerous issues and problems that required FDA oversight.
During the inspection of the SimplyThick plant, the FDA discovered that Thermo Pac, LLC (the makers of Simply Thick) had failed to properly process the food in a way that would prevent the formation of dangerous bacteria. Their process did not sufficiently remove microorganisms that can be potentially harmful to the recipient’s health. The Food and drug administration also found bacillus cereus, a certain type of bacteria in 12 of the 30 samples taken from the Simply Thick plant. In June of 2011, the Food and Drug Administration issued an FDA Simply Thick recall of all the product that was manufactured at that Stone Mountain location.
The manufacturing at this Stone Mountain plant was not halted for very long, as it resumed production in July of the same year. After it had been reintroduced to the market, the Food and Drug Administration (FDA) warned that the product may increase the risk of necrotizing enterocolitis among infants who were born prematurely as well as those born full-term. Previously, professionals believed that SimplyThick may only cause Necrotizing Enterocolitis (NEC) if given to premature infants, but new research suggests that all infants may be at risk when given the thickening agent.
The primary ingredient used in the manufacturing of Simply Thick is xanthan gum. A Simply Thick recall lawsuit claims that the intestine of an infant has not developed adequately to handle xanthan gum which may be the cause of necrotizing enterocolitis (NEC) among both premature and full-term infants. Claims against the manufacturers of Simply Thick also include the notion that Simply Thick did not adequately test, examine, study, or notify parents and medical professionals about all of the potential risks and dangers of giving Simply Thick to infants.
A Simply Thick Recall Lawsuit alleges that the makers of SimplyThick either are aware, or should be aware of all the potentially dangerous consequences of giving their product to infants. Unfortunately, the makers of Simply Thick continued to manufacture their potentially harmful product even spreading misleading information about the supposed safety of their product.
If your child is currently suffering or has suffered from Necrotizing Enterocolitis (NEC), and they took a thickening agent like SimplyThick to supplement breast milk or formula, you may have a potential Simply Thick Recall Lawsuit against the makers of the thickening agent. Women across the nation are currently filing Simply Thick Recall Lawsuits on behalf of their infants suffering from this dangerous condition. Our Simply Thick Lawyers are currently standing by ready to offer a free consultation for your potential SimplyThick Recall lawsuit.