Simply Thick, LLC has recalled its SimplyThick® thickening gel products manufactured since June 1, 2009 at a food processing plant located in Stone Mountain, Ga. This plant is currently owned and operated by Thermo Pac, LLC. This recall is limited to only those products manufactured at the Stone Mountain, Ga. plant. Simply Thick products manufactured at two additional food processing plants are not subject to this voluntary recall. For information on how to identify the products subject to this voluntary recall, you can contact Shanna Malone at Shanna.Malone@beasleyallen.com.
The SimplyThick® thickening gel products 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 recall were distributed across the United States and Canada through food service distributors, drug distributors, retail outlets (consisting primarily of pharmacies and durable medical equipment suppliers), medical facilities, and directly to consumers.
The company has notified its customers and medical professionals in Canada and in the United States and required them to follow the FDA’s and the Canadian Food Inspection Agency’s (CFIA) warning not to give SimplyThick® brand thickener to infants born before 37 weeks gestation who are currently receiving hospital care or have been discharged from the hospital in the past 30 days, pending the results of investigations by the company, the FDA and the CFIA.
The company warns against the use of SimplyThick® brand thickener with infants born before 37 weeks gestation who are currently receiving hospital care or have been discharged from the hospital in the past 30 days regardless of whether or not the product is affected by the recall. Anyone who has purchased or who has SimplyThick® thickening gel products manufactured at a food processing plant located in Stone Mountain, Ga. should contact the company directly at 1-800-205-7115 for a full refund or an exchange for product(s) unaffected by the recall. Consumers with questions may contact the company at its toll free number 1-800-205-7115 24 hours a day, or by email at firstname.lastname@example.org.
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