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SIMPLYTHICK VOLUNTARY RECALL INFORMATION

Kinder  Products Ltd.

Food service solutions for facility & home care

June 7, 2011                                                                                                      

Dear Valued Customer:

Please be advised that SimplyThick LLC is conducting a Voluntary Recall of Individual and Bulk packets of SimplyThick, which have been manufactured at a food processing plant located in Stone Mountain, Georgia.  SimplyThick products manufactured at two additional food processing plants are not subject to this voluntary recall.

The details of the voluntary recall are in the announcement issued by SimplyThick, which is at the end of this page.  A summary of the products that are being recalled are as follows:

·         All of the Individual Packets (15g & 30g)

·         Some of the Bulk Packets (120g & 240g) – Identified with a “TP” in the lot code stamped into the edge of the product.

·         Bottles of SimplyThick are NOT being recalled as they were manufactured in a different plant.

 

Please call Kinder Products at 800-672-3879 to get replacements or refunds for the recalled products.  Courier return labels will also be provided in order to pick up recalled products, as they must be returned to our offices for destruction. 

I apologize for the inconvenience and concern that this causes, and will provide updated information as soon as it is available.

 Kind regards,

Colette Gauthier
President

Kinder Products Ltd.

Phone: 800-672-3879

Fax:  403-609-3542

info@kinderproducts.ca

www.kinderproducts.ca



 

 

 

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

 

  

June 4, 2011

 

 

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 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.

 

For information on how to identify the products subject to this voluntary recall, please see the section below: How To Determine If The Product Was Manufactured At The Stone Mountain, GA Plant.

 

 

WHY THE VOLUNTARY RECALL WAS ANNOUNCED

 

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 the manufacturer 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 manufacturer's Stone Mountain plant conducted from May 23 through June 3, 2011.

 

 

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 (consisting primarily of pharmacies and durable medical equipment suppliers), medical facilities, and directly to consumers.

 

 

HOW TO DETERMINE IF THE PRODUCT WAS MANUFACTURED AT THE STONE MOUNTAIN, GA PLANT

 

Products affected:  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 on the edge of each packet.  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 .  Here is an example of this packet http://bit.ly/lq9FiW.

 

A complete list of affected date codes are posted on the SimplyThick website at www.simplythick.com/recalleddatecodes .

 

Products NOT affected by the recall:

 

64 oz bottles

 

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

 

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

 

 

SimplyThick item numbers NOT affected:

 

05000, 05005, 05010

 

Some 01004, 02004, 01006 and 02006  - identified as those with a "W" 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.

 

Example of a date code NOT affected by recall:  04051211WB.  "Best If Used By Date" is 04/05/12 - i.e. April 5, 2012 AND it contains "W" in the code.  See picture for what it looks like on a packet at this link:  http://bit.ly/lvpCss.    

 

SHOULD THE FDA WARNING CONTINUE TO BE FOLLOWED REGARDING PREMATURE BABIES?

 

Yes. 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. 

 

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.

 

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 is urged to return the product to the point of purchase for a refund or exchange or contact the company directly at 1-800-205-7115 for a 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.