On May 20, 2011, the FDA issued an official warning stating that the "FDA Warns Not to Feed SimplyThick to Premature Infants". This official warning came before an FDA inspection of the food processing plant in Stone Mountain, Georgia where the product is manufactured. During this inspection, it was discovered that the plant did not perform a process required to kill harmful bacteria within the product. This warning was the official start of a still-ongoing investigation in which the bacterial contamination disease necrotizing enterocolitis (NEC) was discovered in 15 infants who were given the product. Two of the infants have died at this time. Further instances of necrotizing enterocolitis (NEC) may have occurred in a number of other yet to be reported cases. For more information on this product recall, please contact Shrader & Associates at 888-637-6236 or visit http://www.shraderlaw.com.
On June 5, 2011, two weeks after the FDA warning http://www.fda.gov/NewsEvents/newsroom/PressAnnouncements/ucm256253.htm was issued, Simply Thick, LLC, announced the voluntary recall of products that were manufactured on their behalf by Thermo Pac, LLC at the food processing plant located in Stone Mountain, Georgia. At this time, Simply Thick, LLC has voluntarily recalled only products made at the Stone Mountain, Georgia food processing plant. Shrader & Associates a national law firm specializing in product recalls and product liability provides the most recent recall information to clients and other interested persons at http://www.shraderlaw.com/simplythick-recall-advisory.
Current Recall Information
?At this time, the affected Simply Thick product could be in the homes of thousands,? warn product safety attorneys at Shrader & Associates. The Simply Thick, LLC recall includes products from the Stone Mountain, GA plant, which distributes the product across the United States and Canada. The SimplyThick product was placed in retail outlets, sold by drug distributors, sold by food service distributors, was provided to medical facilities including doctor's offices and hospitals, and was sold directly to consumers in stores.
FDA press release with Simply Thick, LLC recall product information may be found at http://www.fda.gov/Safety/Recalls/ucm257841.htm
While these are, at the current time, the only product lots known to be affected, future recalls are always possible and it is imperative that any person who has purchased this product use extreme caution with it, and keep a close watch for any SimplyThick side effects. The FDA investigation is still ongoing, and the total number of affected products is yet unknown. The number of infants harmed or killed is likewise unknown at this time.
Necrotizing Enterocolitis (NEC)
The bacterial contamination disease known as necrotizing enterocolitis causes the tissue in the intestines to become inflamed, and then die as a result of the extreme inflammation. In a premature infant, whose defenses are still developing, necrotizing enterocolitis can cause severe illness and death, as in the two dead infants discovered thus far in the FDA investigation. When products such as SimplyThick are manufactured, very rigid safety standards, set in place by the FDA, must be strictly observed to avoid any type of bacterial contamination. There is more information from Shrader & Associates about necrotizing enterocolitis at http://www.shraderlaw.com/necrotizing-enterocolitis-simplythick-side-effect.
Shrader & Associates, LLP fights for the rights of families who have been affected by necrotizing enterocolitis (NEC). Because safety standards were not followed, as in the case of the Simply Thick recall, thousands of infants could potentially be affected. Any person who needs to learn more about the SimplyThick recall, or necrotizing enterocolitis (NEC) side effects is urged to contact the attorneys of Shrader & Associates who specialize in product liability and product recalls at 888-637-6236, or visits us on the web at http://www.shraderlaw.com/simplythick-recall-advisory for help with their case.
For More Information: http://www.ShraderLaw.com
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