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Simply Thick Recall Lawsuit

Posted on Jun 6, 2011 in Medical Products

Our attorneys are representing several families whose premature infants developed necrotizing enterocolitis (NEC) after being fed Simply Thick. In some of the cases, the infants died. In others, the infants required surgery to remove part of the intestine (bowel). These cases have not been linked to the Simply Thick recall. Only the products listed below are involved in the recall.

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Simply Thick, LLC has recalled its SimplyThick® thickening gel products manufactured at a food processing plant located in Stone Mountain, Georgia since June 1, 2009. This plant is currently owned and operated by Thermo Pac, LLC. Our attorneys and the FDA are investigating this Simply Thick recall to determine if it is related to the cases of NEC in premature infants. If there is a link between the recalled SimplyThick and the cases of NEC, families may have claims against both Simply Thick, LLC and Thermo Pac, LLC.

The SimplyThick® thickening gel products manufactured at the Thermo Pac, LLC Stone Mountain plant are being recalled because the U.S. Food and Drug Administration (FDA) advised the company that Thermo Pac, LLC failed to file with the FDA a scheduled process designed to ensure that vegetative cells 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.

Important Note: Until the completion of the investigations into the connection between SimplyThick brand thickener and NEC, the FDA is continuing to warn 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.

What Products are Affected by the Simply Thick Recall?

Only SimplyThick thickening gel manufactured at the Stone Mountain, Georgia plant are affected by this recall. To determine if your SimplyThick gel was manufactured at Stone Mountain, please see below:

Products affected are 15 g, 30 g, 120 g and 240 g pouches.
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.

All products have a code embossed or stamped in 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.

An example of an affected date code is: 0312125TP1. The code breakdown would be the “Best If Used By Date”, 03/12/12 – i.e. March 12, 2012 AND it contains “TP” in the code .

Packets Code Dates Affected:

15 g packets (Nectar Individual Packets):

Embossed / Imprinted Date
080110#TP#
080210#TP#
082110#TP#
082210#TP#
082310#TP#
082410#TP#
082810#TP#
082910#TP#
092610#TP#
092710#TP#
092810#TP#
100310#TP#
101710#TP#
101810#TP#
101910#TP#
111310#TP#
111410#TP#
111510#TP#
111610#TP#
120410#TP#
121110#TP#
121210#TP#
010111#TP#
010211#TP#
010511#TP#
012911#TP#
013011#TP#
031311#TP#
031411#TP#
031511#TP#
032611#TP#
032711#TP#
032811#TP#
032911#TP#
041711#TP#
041811#TP#
050211#TP#
050311#TP#
050411#TP#
052111#TP#
052211#TP#
052311#TP#
052411#TP#
052511#TP#
052811#TP#
062611#TP#
062711#TP#
062811#TP#
062911#TP#
073111#TP#
080111#TP#
080211#TP#
080311#TP#
080411#TP#
080611#TP#
082711#TP#
082811#TP#
082911#TP#
091711#TP#
091811#TP#
091911#TP#
102911#TP#
103011#TP#
103111#TP#
110111#TP#
110211#TP#
110311#TP#
111211#TP#
111311#TP#
111411#TP#
111511#TP#
112011#TP#
112611#TP#
112711#TP#
120411#TP#
120511#TP#
120611#TP#
121011#TP#
121111#TP#
121211#TP#
121311#TP#
123111#TP#
010112#TP#
012212#TP#
012312#TP#
012412#TP#
012812#TP#
012912#TP#
013012#TP#
013112#TP#
020912#TP#
021212#TP#
021312#TP#
021412#TP#
021812#TP#
021912#TP#
031012#TP#
031112#TP#
031212#TP#
031312#TP#
031412#TP#
031912#TP#
032012#TP#
041412#TP#
041512#TP#
041612#TP#
050512#TP#
050612#TP#
050712#TP#
050812#TP#
050912#TP#
052112#TP#
052212#TP#
060212#TP#
060312#TP#
060412#TP#
060512#TP#

30 g Packets (Honey Individual Packets):

Embossed / Imprinted Date
062610#TP#
062710#TP#
080210#TP#
080310#TP#
082910#TP#
090410#TP#
090510#TP#
100310#TP#
100410#TP#
100510#TP#
101610#TP#
101710#TP#
120410#TP#
120510#TP#
120610#TP#
121210#TP#
121310#TP#
010211#TP#
010311#TP#
010411#TP#
030711#TP#
030811#TP#
030911#TP#
031211#TP#
031311#TP#
041611#TP#
041711#TP#
041911#TP#
042011#TP#
043011#TP#
050111#TP#
052811#TP#
052911#TP#
053011#TP#
060411#TP#
061811#TP#
061911#TP#
062011#TP#
080611#TP#
080711#TP#
080811#TP#
082911#TP#
083011#TP#
083111#TP#
091011#TP#
091111#TP#
091211#TP#
091711#TP#
100811#TP#
100911#TP#
101011#TP#
110511#TP#
110611#TP#
110711#TP#
110811#TP#
111911#TP#
112011#TP#
121011#TP#
121111#TP#
121211#TP#
121311#TP#
123111#TP#
010112#TP#
012212#TP#
012312#TP#
012812#TP#
012912#TP#
013012#TP#
013112#TP#
022012#TP#
022112#TP#
031712#TP#
031812#TP#
031912#TP#
041512#TP#
041612#TP#
041712#TP#
050512#TP#
050612#TP#
050712#TP#
050812#TP#
052212#TP#
052612#TP#
052712#TP#
052812#TP#

120g Packets (Nectar Bulk Packets)

Embossed / Imprinted Date
062710#TP#
080410#TP#
103110#TP#
110110#TP#
121910#TP#
122010#TP#
012911#TP#
030711#TP#
030811#TP#
070211#TP#
070311#TP#
070411#TP#
080811#TP#
102211#TP#
102311#TP#
120411#TP#
021812#TP#
032412#TP#
060912#TP#
061012#TP#

240g Packets (Honey Bulk Packets)

Embossed / Imprinted Date
062710#TP#
062810#TP#
080410#TP#
110110#TP#
110210#TP#
112010#TP#
112110#TP#
121810#TP#
121910#TP#
012911#TP#
013011#TP#
030611#TP#
030711#TP#
070211#TP#
070311#TP#
070411#TP#
080911#TP#
102311#TP#
102411#TP#
120511#TP#
120611#TP#
120711#TP#
021912#TP#
022012#TP#
032512#TP#
061012#TP#
061112#TP#

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 (consisting primarily of pharmacies and durable medical equipment suppliers), medical facilities, and directly to consumers. This voluntary recall is limited to only those products manufactured at the Stone Mountain, Georgia plant. Simply Thick products manufactured at two additional food processing plants are not subject to this voluntary recall.