Recall of SimplyThick Products from Stone Mountain Plant

The U.S. Food and Drug Administration is warning all parents not to feed their infants SimplyThick products.

An updated warning went out earlier this week, as SimplyThick LLC voluntarily recalled its SimplyThick® thickening gel products, made at a food processing plant in Stone Mountain since June 1, 2009.

The FDA, with the Centers for Disease Control and Prevention,  is looking into a possible link between SimplyThick and necrotizing enterocolitis (NEC) in premature infants, as early indications have suggested.

SimplyThick® is a food and beverage thickener designed for people who have difficulties swallowing.

The recall is limited to the products manufactured at the Stone Mountain plant, which is owned and operated by Thermo Pac, LLC.

The products recalled are:

• All 15 g pouches are affected
• All 30 g pouches are affected
• Some 120 g pouches – identified as those with a "TP" in the lot code stamped into the edge of the packet.
• Some 240 g pouches – identified as those with a "TP" in the lot code stamped into the edge of the packet.

SimplyThick item numbers affected:

• All 01001, 01005, 01007, 02001, 02005, and 02007  
• 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 our packaging.  The item number is the second group of 5 digits in the UPC barcode.

SimplyThick said the recall is in effect “because the U.S. Food and Drug Administration 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.”

The company said the failure was discovered during an FDA inspection of the Thermo Pac, LLC Stone Mountain plant, which was conducted from May 23 through June 3, 2011.