Simply Thick Recall

Simply Thick NEC Our attorneys are representing families whose premature infants developed necrotizing enterocolitis (NEC) after being fed milk thickened with Simply Thick brand thickener. As part of their investigation of these cases, they are investigating a Simply Thick recall involving 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.

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The Simply Thick recall was initiated because the U.S. Food and Drug Administration (FDA) advised the Simply Thick 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, after the FDA had received 15 reports of NEC in premature infants who had been given Simply Thick at the hospital and/or at home. Read about Simply Thick and NEC.

Two of the reports to the FDA involved infants who had died. Our law firm has received contacts from other families whose infants died from NEC after being given Simply Thick.

What Products are Involved in the Simply Thick Recall?

Only SimplyThick thickening gel manufactured at the Stone Mountain, Georgia plant are affected by this recall. Products affected are 15 g, 30 g, 120 g and 240 g pouches:

All 15 g pouches and 30 g pouches are affected.
Some 120 g pouches affected – those identified with a “TP” in the lot code stamped into the edge of the packet.
Some 240 g pouches are affected – those identified 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. Below are the Simply Thick item numbers affected by the recall:

Item Codes 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.

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.

FDA Warning Regarding Simply Thick

FDA has warned parents, hospitals and caregivers not to feed the thickening product called Simply Thick to infants born before 37 weeks gestation because it may cause a life-threatening condition.

This advice to parents, caregivers, and health care providers from the Food and Drug Administration (FDA) is based on reports of infants with necrotizing enterocolitis (NEC) in which tissue in the intestines becomes inflamed and dies.

FDA first learned of bad side effects possibly linked to SimplyThick on May 13, 2011. Silverman says he was alerted by two reports in FDA’s MedWatch Adverse Event Reporting system. He followed up with the physicians who filed those reports and subsequently with a network of other neonatologists.

Karl Klontz, M.D., a medical officer in FDA’s Center for Food Safety and Applied Nutrition, says the severity and scope of the problem soon became apparent. To date, the agency is aware of 15 cases of NEC, including two deaths, involving premature infants who were fed SimplyThick mixed with mothers’ breast milk or infant formula products. The mixture was fed to infants for varying amounts of time.

FDA Advice for Parents and Caregivers

Do not feed SimplyThick to premature infants, including those in the hospital and those sent home from the hospital within the past 30 days.
Contact your health care professional if your baby has any of the symptoms listed above or if you have other concerns related to using SimplyThick.
You or your health care professional, or our attorneys may report side effects related to using SimplyThick to FDA's MedWatch Safety Information and Adverse Event Reporting Program by:
- Completing and submitting the report online: www.fda.gov/MedWatch/report.htm;
- Downloading the pre-addressed, postage-paid FDA Form 3500 (or calling 1-800-332-1088 to request the form), completing it and faxing it to 1-800-FDA-0178; or
- Mailing the completed form to MedWatch 5600 Fishers Lane, Rockville, MD 20857.

Attorneys David Szerlag, Eric Hageman and Fred Pritzker are lead attorneys for our Simply Thick NEC cases. To contact David about a lawsuit against Simply Thick, LLC of St. Louis, Missouri, the manufacturer of SimplyThick®, call 1-888-377-8900 (toll free) or submit our online form for a free consultation.

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