A risk of bacterial contamination has led to the recall of SimplyThick, a thickening gel for people with swallowing problems, which has also been linked to potentially life-threatening problems when used for premature infants.
The SimplyThick recall was announced on June 4, after FDA inspectors discovered that the products manufactured at Thermo Pac, LLC’s Stone Mountain, Georgia manufacturing facility did not have a proper process in place to prevent harmful bacteria contamination. The problem was discovered during an FDA inspection from May 23 to June 3.
The company was required to file a scheduled process with the FDA that would have ensured that harmful bacteria was kept out of SimplyThick, but failed to do so. There have been no reported incidents of Simply Thick bacterial contamination.
SimplyThick is a thickening agent used by both children and adults to treat swallowing disorders. When given to infants, it is added to their formula or milk to help them keep food down without spitting up. It is distributed by SimplyThick, LLC and has been on the market since 2001.
The recall affects only products manufactured at the Stone Mountain, Georgia, facility. The company has two other food processing plants that make SimplyThick that are not included in the recall.
Products affected by the SimplyThick recall includes all 15 g and 30 g pouches, as well as 120 g and 240 g pouches that have a “TP” in the lot code stamped into the edge of the packet. The recall affects all SimplyThick pouches with item numbers 01001, 01005, 01007, 02001, 02005 and 02007, as well as any with item numbers 01004, 02004, 01006, and 02006 that have “TP” in the lot code stamped into the edge of the packet.
The recall comes just days after the FDA issued a SimplyThick public health warning that the solution should not be given to prematurely born infants due to the risk of necrotizing enterocolitis (NEC) that has resulted in the death of at least two infants. That warning still stands, even for SimplyThick that has not been recalled.
The company recommends that anyone who has SimplyThick thickening gel products affected by the recall contact the company for a full refund or replacement products by calling 1-800-205-7115.