On June 5, 2011, the U.S. Food and Drug Administration (FDA), in association with the Centers for Disease Control and Prevention (CDC), announced a nationwide recall of SimplyThick due to the products association with a debilitating condition known as necrotizing enterocolitis.
If you or someone close to you has been diagnosed with necrotizing enterocolitis after consuming SimplyThick, you should contact our SimplyThick lawyers immediately for a free confidential case evaluation. You may be entitled to compensation for your injuries and we can help.
SimplyThick Recall Overview
Thermo Pac, LLC, the owner and operator of the plant where the SimplyThick recall took place, failed to file with the FDA a scheduled process designed to ensure that harmful bacteria, of possible public health significance, are destroyed during the manufacturing process. Accordingly, this failure was acknowledged upon an FDA inspection of their Stone Mountain plant conducted between May 23 and June 3, 2011.
On June 4, a SimplyThick recall took place at the Stone Mountain, GA plant that affected thickening agents produced since June 1, 2009. However, products manufactured at their other facilities remain on the market. The SimplyThick recall is a direct result of the company’s gross negligence and utter failure to ensure that harmful bacteria were destroyed in the manufacturing process at the Stone Mountain manufacturing plant. Accordingly, the SimplyThick products manufactured at other facilities remains on the market and are not subject to the SimplyThick recall.
Products manufactured at the Stone Mountain, GA plant subject to the SimplyThick recall have been distributed throughout the United States and Canada by food service distributors, drug distributors, retail outlets (consisting primarily of pharmacies and durable medical equipment suppliers), medical facilities, and directly to consumers.
Affected SimplyThick Products
The following SimplyThick products were affected by the SimplyThick recall:
- 15g pouches
- 30g pouches
- 120g pouches
- 240g pouches
Affected SimplyThick Item Numbers
SimplyThick products with the following item numbers have been affected by the recall:
- 01001
- 01005
- 01007
- 02001
- 02005
- 02007
- 01004
- 02004
- 01006
- 02006
Item numbers are included as part of the UPC barcode on SimplyThick packaging. The item number is located on the second group consisting of 5 digits on the UPC barcode.
All SimplyThick products have a code embossed on the foil. The first 6 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. Each of these products, with their corresponding item numbers, has the potential to cause severe side effects. Due to the severity of these complications, people have begun to seek compensation for their pain and suffering by filing a SimplyThick lawsuit.
Symptoms of Necrotizing Enterocolitis
Necrotizing Enterocolitis is a condition in which the intestine becomes infected and inflamed. In many cases, the infected tissue detaches itself from the wall of the intestine. In severe cases, the symptoms can manifest themselves into a potentially fatal complication. Due to the severity of these complications, numerous people have sought compensation for their pain and suffering by filing their own SimplyThick lawsuit.
SimplyThick FDA Warning
The following is an official FDA press release:
The FDA is advising parents, caregivers and health care providers not to feed SimplyThick, a thickening product, to premature infants. The product may cause necrotizing enterocolitis (NEC), a life-threatening condition.
FDA first learned of adverse events possibly linked to the product on May 13, 2011. To date, 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.
Illnesses have been reported from at least four different medical centers around the country. The illnesses of which FDA is aware involve premature infants who became sick over the past six months. SimplyThick was added to the feeding regimen of those infants who later developed NEC to help with swallowing difficulties stemming from complications of premature birth.
Do I have a SimplyThick Lawsuit?
The trial lawyers at The Senators (Ret.) Firm, LLP have decades of experience navigating through complex legislative and regulatory issues and litigating high stakes cases all over the nation. Our law firm focuses on the representation of plaintiffs in SimplyThick lawsuits. We are currently accepting new cases in all 50 states.
If you or someone close to you has been diagnosed with necrotizing enterocolitis after consuming SimplyThick, you should contact our lawyers immediately by clicking the link below or calling toll free 1-(949) 557-5800. You may be entitled to compensation for your injuries and we can help.