SimplyThick Recall News

Resumption of Shipment for SimplyThick 15g and 30g packets

SimplyThick, LLC — Thu, 07 Jul 2011 22:58:00 -0000

July 6, 2011: SimplyThick, LLC announces that it has resumed shipping limited quantities of its product in 15g and 30g packets following FDA’s determination that the Stone Mountain, GA processing plant’s redesigned procedures ensure a commercially sterile product.

To easily distinguish these new 15g and 30g packets from any 15g and 30g packets that are subject to our voluntary recall, the product code stamp on the side of the new pouches has been reconfigured. The new code stamp begins with the letters “ EXP ” and does NOT include the letter “ T ”. The code stamp affected by the voluntary recall begins with 7 numbers followed by “ TP ”. More details can be found by clicking here .

In addition, consistent with the FDA’s May 20 warning , boxes containing the new 15g and 30g packets will be labeled "WARNING: Do Not Feed SimplyThick to Premature Infants". Link to FDA warning site.

Identifying new small SimplyThick packets

SimplyThick: The Thickening Gel You Can't Taste! — Wed, 06 Jul 2011 05:00:00 -0000

How to tell the difference between small packets of SimplyThick (15g and 30g) that are affected by the June 4, 2011 recall:

By shipping date

All 15 and 30 g packets shipped after July 5, 2011 are NOT affected by the recall. If you had 15g or 30g packets shipped to you prior to July 5, 2011, they ARE affected by the voluntary recall. Please click here for assistance with a refund or an exchange .

By the code on the side of the packet

All products have a code embossed or stamped in the foil. The new codes that is NOT affected by the recall begins with the letters “EXP” and has a letter “S” in the code date. See the photo below:

The old codes that are affected by the voluntary recall have the letters “ TP ” in the stamped code. See the photo below:

By warning label

Prior to July 5, 2011, orange warning labels were on every shipping container of SimplyThick. With the new production process from the Stone Mountain, GA facility, we will have warning labels on every carton of SimplyThick with 15g and 30g pouches. See the example image below:

Recall Update for 6/16/2011

SimplyThick, LLC — Thu, 16 Jun 2011 17:04:00 -0000

PLEASE NOTE – Regarding the voluntary recall, we are helping everyone as quickly as possible and diligently working to process all requests. Obviously, our primary focus is on getting replacement product in the hands of those who are currently using the product.

The overall process of sending return labels and processing refunds is proceeding as quickly as possible with a current estimate of approximately 2 to 3 weeks.

SimplyThick Announces Voluntary Recall

SimplyThick, LLC — Sun, 05 Jun 2011 16:53:00 -0000

Important Announcement: June 4, 2011

SIMPLY THICK, LLC ANNOUNCES THE VOLUNTARY RECALL OF PRODUCTS MANUFACTURED BY THERMO PAC, LLC AT THEIR STONE MOUNTAIN, GA FOOD PROCESSING PLANT

Click Here to Access our Recall Return / Exchange Form

St. Louis, MO -- Simply Thick, LLC is announcing a voluntary recall of 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. 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 .

Click here for information on how to identify the products subject to this voluntary recall.

Anyone who has purchased or who has SimplyThick® thickening gel products manufactured at a food processing plant located in Stone Mountain, Georgia is urged to return the product to the point of purchase for a refund or exchange or contact SimplyThick 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 latestinfo@simplythick.com .

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 (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.

On May 20, 2011, the company notified our customers and medical professionals in Canada and in the United States 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 our, the FDA’s and the CFIA’s investigations View the FDA press release here..

At this time, Simply Thick has not been advised by the FDA as to whether there is a relationship between the FDA’s previous warning and the FDA’s recent discovery that Thermo Pac, LLC failed to file a certain process with the agency.

Until the FDA, the CFIA and our company have completed our investigations, we continue 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.

Click Here to Access our Recall Return / Exchange Form

For additional information, please call 800-205-7115 or email latestinfo@simplythick.com .

How to identify the products subject to the SimplyThick voluntary recall

SimplyThick: The Thickening Gel You Can't Taste! — Sat, 04 Jun 2011 05:00:00 -0000

July 5, 2011 – UPDATE – SimplyThick, LLC has begun shipping limited quantities of 15 and 30g packets made from the Stone Mountain, GA facility. The information has been updated below to reflect this new information.

The overall process of sending return labels and processing refunds is proceeding as quickly as possible with a current estimate of approximately 2 to 3 weeks.

Simply Thick, LLC is announcing a voluntary recall of 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. 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.

WHY THE VOLUNTARY RECALL WAS ANNOUNCED

HOW TO IDENTIFY THE PRODUCT

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 and directly to the public.

HOW TO DETERMINE IF THE PRODUCT YOU HAVE IS AFFECTED BY THE RECALL

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

All 15 g pouches shipped before June 3, 2011 are affected – identified as those with a “TP” in the lot code stamped into the edge of the packet.

All 30 g pouches shipped before June 3, 2011 are affected – identified as those with a “TP” in the lot code stamped into the edge of the packet.

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 product codes affected

ALL 01001, 01005, 01007, 02001, 02005, and 02007

SOME 01004 and 02004 – identified as those with a “TP” in the lot code stamped into the edge of the packet.

Products NOT affected by the recall:

64 oz bottles

Some 15g pouches – identified as those with a “EXP” in the lot code stamped into the edge of the packet and/or shipped on or after July 5, 2011

Some 30g pouches – identified as those with a “EXP” in the lot code stamped into the edge of the packet and/or shipped on or after July 5, 2011

Some 120g pouches – identified as those with a “W” in the lot code stamped into the edge of the packet.

Some 240g pouches – identified as those with a “W” in the lot code stamped into the edge of the packet.

SimplyThick product codes NOT affected:

05000, 05005, 05010

SOME 01004 and 02004 – identified as those with a “W” in the lot code stamped into the edge of the packet.

SOME 01001, 01005, 01007, 02001, 02005 and 02007 – identified as those with a “EXP” in the lot code stamped into the edge of the packet and/or shipped on or after July 5, 2011.

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 022508 (i.e. February 25, 2008) and 062612 (i.e. June 26, 2012) and contains the letter code “TP” in the code are affected by the recall. See images below for more detail:

The “W” or "EXP" on packets NOT affected by the recall will appear similar to the images below:

The "TP" on packets which ARE affected by the recall will appear similar to the image below:

IDENTIFICATION BY SHIPPING BOX

You can also identify affected 01004 and 02004 products by the labeling on the shipping box that your product came in. If you see a tall, rectangular label on the corner of the broad side of the shipping box, with the numbers "004150" or "004152" on the second line of text, the packets are NOT being recalled. If your box includes a wider label on the narrow side of the shipping box, with only two lines of text, you should discontinue use and return the remaining product as this case of packets is being recalled. The image below provides more detail:

WHAT TO DO IF YOU HAVE PRODUCTS MANUFACTURED AT THE STONE MOUNTAIN GA PLANT THAT ARE SUBJECT TO THE VOLUNTARY RECALL

Anyone who has purchased or who has SimplyThick® thickening gel products manufactured at a food processing plant located in Stone Mountain, Georgia are urged to return them to the point of purchase for or contact the company directly at 1-800-205-7115 a full refund or to exchange for product(s) unaffected by the recall. Consumers with questions may contact the company at its toll free number 1-800-205-7115 or by email at latestinfo@simplythick.com .

SimplyThick NEC Advisory

SimplyThick, LLC — Sat, 21 May 2011 16:38:00 -0000

SimplyThick is advising our customers and medical professionals to follow the FDA’s recommendation that SimplyThick® brand thickener not be used with or given to babies who were born before 37 weeks. View the FDA press release here.

We hope that this does not cause any inconvenience to medical professionals or our customers but, as you can understand, Simply Thick wants to proceed with all due caution. If you would like additional information, please call 800-205-7115 or email latestinfo@simplythick.com .