Simply Thick, LLC is recalling some of its <"https://www.yourlawyer.com/practice_areas/product_liability">SimplyThick® thickening gel products manufactured at a Stone Mountain, Georgia food processing plant since June 1, 2009, the U.S. Food and Drug Administration (FDA) announced. This plant is currently owned and operated by Thermo Pac, LLC and the recall is limited to those products manufactured at that plant. SimplyThick products manufactured at two additional food processing plants are not subject to this voluntary recall.
We recently wrote that the (FDA) warned parents, caretakers, and health care providers not to use SimplyThick in feedings to premature infants born before 37 weeks. The thickening product, used in the management of swallowing disorders, may cause necrotizing enterocolitis (NEC), a life-threatening condition characterized by inflammation and death of intestinal tissue. The FDA first learned of adverse events possibly linked to SimplyThick on May 13, 2011. As of our last reporting, the agency is aware of 15 cases of NEC, including two deaths, involving premature infants who were fed SimplyThick for varying amounts of time. The product was mixed with mothers’ breast milk or infant formula products.
Now, says the FDA, the SimplyThick® thickening gel products manufactured at the Thermo Pac, LLC Stone Mountain plant are being recalled because the 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.
Products manufactured at the Stone Mountain, Ga. plant subject to the voluntary recall were distributed across the United States and Canada through food service distributors, drug distributors, retail outlets (primarily pharmacies and durable medical equipment suppliers), medical facilities, and directly to consumers. Products affected are 15 g, 30 g, 120 g and 240 g pouches. All 15 g and 30 g pouches are affected. Some 120 g pouches and some 240 g pouches are affected; these pouches can be identified as those with a “TP†in the lot code stamped into the edge of the packet.
SimplyThick item numbers involved are all 01001, 01005, 01007, 02001, 02005, and 02007 and some 01004, 02004, 01006 and 02006 (identified as those with a “TP†in the lot code stamped into the edge of the packet).
SimplyThick item numbers are included as part of the UPC barcode on its packaging; the item number is the second group of five digits in the UPC barcode. All products have a code embossed or stamped in the foil. The first six digits of that code represent a “best if used by†date in MMDDYY format. ANY date code that falls between 062610 (i.e. June 26, 2010) and 062612 (i.e. June 26, 2012) and contains the letter code “TP†in the code are affected by the recall.
An example of an affected date code is: 0312125TP1. The code breakdown would be the “Best If Used By Dateâ€, 03/12/12 – i.e. March 12, 2012 AND it contains “TP†in the code. A picture of a packet with this date code can be found on the firm’s website. Also, a complete list of affected date codes will be posted on the SimplyThick website at www.simplythick.com/recalleddatecodes within the next day.
Anyone who has purchased or who has SimplyThick® thickening gel products manufactured at a food processing plant located in Stone Mountain, Georgia is urged to contact the company directly at 1.800.205.7115 for a full refund or an exchange for product(s) unaffected by the recall. The number is available 24 hours a day. The firm can also be reached by email at [email protected].
The FDA warning concerning premature babies and SimplyThick should continue to be followed.
