Great Value Half & Half

Great Value Heavy Whipping Cream

Kroger Heavy Whipping Cream

Wholesome Farms Chocolate Ice cream Mix

Morningstar Foods is voluntarily recalling the products because they may contain soy protein. The plant code for all the recalled products is: 21-031.

People who have a known allergy to soy protein may have a reaction to these products. Common symptoms of an allergic reaction include hives, swelling, shortness of breath, wheezing, vomiting and stomach or intestinal upset. If a consumer experiences any of the above symptoms, they should see their health care professional immediately. If left untreated, severe allergic reaction can be fatal. No reactions have been reported. The problem was discovered when consumers reported off-taste in some of these products.

Here are the recalled dairy products, listed with the product’s name, UPC code, item code, and plant code.
* 32-ounce Great Value Half & Half, UPC 6 05388 187 16 1, item code 1871600, plant code 21-031;
* 32-ounce Great Value 36% Heavy Whipping Cream, UPC 6 05388 187 18 5, item code 1871800, plant code 21-031;
* 32-ounce Kroger brand 36% Heavy Whipping Cream, UPC 0 11110 438 28 7, item code 4382900, plant code 21-031; and
* 64-ounce Wholesome Farms Chocolate Ice Cream Mix, UPC 0 74865 57 983 4 (if purchased in a multi-pack, the UPC code is 1 00 74865 57983 1), item code 5798300, plant code 21-031.

Each carton is printed with a “use by” date. For the Great Value products, it is December 16, 2009. The Kroger products have a “use by” date of December 16 and 17, 2009 and the Wholesome Farms product is January 7, 2010. Consumers can find the expiration date and the plant code on the top of the gable top package. The UPC code will either be located on the back or the side panel of the gable top carton. No other Great Value, Kroger or Wholesome Farms products are involved in this recall.

The affected product was distributed to retail outlets in the following states: Alabama, Connecticut, Florida, Georgia, Iowa, Illinois, Indiana, Kansas, Kentucky, Louisiana, Maine, Maryland, Massachusetts, Michigan, Minnesota, Missouri, New Hampshire, Nebraska, New York, North Carolina, North Dakota, Ohio, Pennsylvania, Rhode Island, South Carolina, Tennessee, Texas, Vermont, Virginia, West Virginia and Wisconsin. Morningstar Foods’ sales team is working with distributors to actively recover any affected product remaining on store shelves.

HOW TO IDENTIFY THE RECALLED PRODUCT
This recall includes only the products listed below. Each product is sold in a cardboard gable-top carton. Consumers can find the expiration date and the plant code on the top of the gable top package. The UPC code will either be located on the back or the side panel of the gable top carton. No other Great Value, Kroger or Wholesome Farm products are involved in this recall.

* 32-ounce Great Value Half & Half: UPC 6 05388 187 16 1, item code 1871600, plant code 21-031, “use by” date of December 16, 2009
* 32-ounce Great Value 36% Heavy Whipping Cream: UPC 6 05388 187 18 5, item code 1871800, plant code 21-031, “use by” date of December 16, 2009
* 32-ounce Kroger brand 36% Heavy Whipping Cream: UPC 0 11110 438 28 7, item code 4382900, plant code 21-031, “use by” date of December 16 and 17, 2009
* 64-ounce Wholesome Farms Chocolate Ice Cream Mix: UPC 0 74865 57 983 4, item code 5798300, plant code 21-031, “use by” date of January 7, 2010 (if purchased in a multi-pack, the UPC code is 1 00 74865 57983 1)

The Company apologizes for any inconvenience to its customers. Consumers who purchased the product may return it to the place of purchase for a full refund or exchange. Consumers with questions can contact the Company at 800-854-3243 from 8 a.m. – 5 p.m. Central Time.

The Food and Drug Administration has been notified of this recall.

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Photos: Product Labels

When you buy groceries, you expect the food to be safe.  If there is a problem and food is found to not be safe, you expect that food to be removed from store shelves immediately.  For the most part, that is what happens.  Food manufacturers and suppliers will do a voluntary recall of a product when it is discovered that the food is defective, not labeled properly,  or unsafe in any way.  The FDA also issues food recalls.

The Food Industry has had it’s own recall system in place for years which complies with the requirements of the Food and Drug Administration (FDA) Reportable Food Registry.  That system has just been replaced with a new standardized food recall system.  Named “Rapid Recall Exchange”, the new system was launched Sept. 21st by the Food Marketing Institute (FMI) and GS1 US™.

Will Benefit The Public

Rapid Recall Exchange is an on-line service to enable prompt and accurate information exchange between food industry retailers, wholesalers, and suppliers about food recalls and products withdrawn from the market.

” Rapid Recall Exchange represents industry consensus that a standardized product recall system is critical to enhancing effective communication.  It is a system designed by the industry and for the industry, which applies best practices and critical insight and expertise from industry partners and associations,” said Leslie G. Sarasin, FMI President and CEO.

Bob Carpenter, CEO of GS1 US stated,  “This will benefit the public as well as the companies that use it.  It employes the same GS1 global standards that these companies already use to identify their products, stock their shelves, and accelerate check-outs.  Its ease of use and extensive functionality can improve the speed and accuracy of recalls, which we all want.”

Supported by GMA and N.G.A.

Rapid Recall Exchange is supported by the Grocery Manufacturers Association (GMA) and National Grocers Association (N.G.A.).

The president and CEO of GMA, Pamela G. Bailey stated,  “Manufacturers are eager to work closely with retailers and wholesalers to facilitate information exchange, especially during the urgent time of a product recall.  We are pleased to support this unique tool that will help protect consumers by providing critical product information directly to those who can act on it quickly.”

Tom Zaucha, president and CEO of the National Grocers Association, had this to say,  “N.G.A. is encouraged with the progress and direction of the Rapid Recall Exchange.  This is a critical initiative for our industry that requires leadership and proven solutions on such an important consumer issue.  Additionally, we are pleased to be working with FMI, GMA, and GS1 US and soon other associations to strengthen our product recall process.

More information is available at http://www.rapidrecallexchange.org.

FDA Warning

Q. What types of products are affected by this public health advisory?

A. FDA is warning consumers about products that are being marketed for body building and that claim to contain steroids or steroid-like substances. These products are sold online and in retail stores and are promoted as hormone products and/or as alternatives to anabolic steroids for increasing muscle mass and strength. Many of these products are labeled as dietary supplements and make claims about the ability of the active ingredients to enhance or diminish androgen, estrogen, or progestin-like effects in the body. Consumers should be aware that these products are potentially harmful and that FDA has not approved them nor reviewed their safety before marketing.

Q. What are some examples of these types of products?

A. These body building products are often marketed as being anabolic (promoting muscle building) and/or being similar to anabolic steroids (such as testosterone). The products included in the warning letter to American Cellular Laboratories Inc. provide a few examples of the body building products about which FDA has safety concerns. The product names and ingredients listed in the warning letter are:

• TREN-Xtreme: 19-Norandrosta-4,9-diene-3,17 dione, marketed as “similar to Trenbolone”
• MASS Xtreme: 17α-methyl-etioallocholan-2-ene-17b-ol, marketed as “similar to Methyl Testosterone”
• ESTRO Xtreme: 4-hydroxyandrostenedione (4-OHA)
• AH-89-Xtreme: 5α-androstano[3,2-c]pyrazole-3-one-17β-ol-THP-ether, marketed as “similar to Stanozolol”
• HMG Xtreme: 2α,3α-epithio-17α-methyl-17β-hydroxy-5α-etioallocholane
• MMA-3 Xtreme: Androsta-1,4-dien-3,17-dione, marketed as “similar to Boldenone (Equipoise)”
• VNS-9 Xtreme: 17α-methyl-4-chloro-androsta-1,4-diene-3β,17β-diol, marketed as “similar to Turinabol”
• TT-40-Xtreme: 1-androsterone, marketed as “very similar to 1-Testosterone” and “converts to 1-Testosterone”

Q. What are the health risks of these types of products?

A. Adverse event reports received by FDA for body building products that are labeled to contain steroids or steroid alternatives involve men (ages 22-55) and include cases of serious liver injury, stroke, kidney failure and pulmonary embolism (blockage of an artery in the lung). Acute liver injury is known to be a possible harmful effect of using anabolic steroid-containing products. In addition, anabolic steroids may cause other serious long-term adverse health consequences in men, women, and children. These include shrinkage of the testes and male infertility, masculinization of women, breast enlargement in males, short stature in children, adverse effects on blood lipid levels, and increased risk of heart attack and stroke.

Q. Why does FDA say these products are illegally marketed?

A. These products are NOT dietary supplements because they contain synthetic steroid or steroid-like active ingredients. These products are unapproved new drugs because they are not generally recognized as safe and effective. In fact, they are potentially harmful. In addition, the products are misbranded because the labeling is misleading and does not provide adequate directions for use.

Q. What action is FDA taking?

A. FDA has issued a public health advisory to highlight the risks of products that are marketed for body building and that contain or claim to contain steroids or steroid-like substances. The agency has executed a search warrant and issued a warning letter to American Cellular Laboratories Inc., which markets a number of these products, because the products are unapproved new drugs and are misbranded. FDA is gathering and reviewing additional data about other products that are marketed for body building and that claim to contain steroids or steroid-like substances.

Q. What should consumers do if they have been using these products?

A. Due to the potential serious health risks, FDA recommends that consumers immediately stop using these products. Consumers should also consult their health care professional if they are experiencing symptoms possibly associated with these products, particularly nausea, weakness or fatigue, fever, abdominal pain, chest pain, shortness of breath, yellowing of the skin or whites of the eyes, or brown/discolored urine. FDA also recommends that consumers talk with their health care professional about body building supplements they are taking, particularly if they are uncertain about the product’s ingredients.

These products are often promoted to athletes to improve sports performance and to aid in recovery from training and sporting events. FDA cautions that athletes taking these products may test positive for performance-enhancing drugs.

Q. How should consumers report problems to FDA?

A. Report serious side effects or product quality problems with the use of these products to FDA’s MedWatch Adverse Event Reporting program online, by regular mail, fax, or phone.

• Online
• Regular Mail: Use FDA postage paid form 3500 and mail to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787
• Fax: 800-FDA-0178
• Phone: 800-FDA-1088

This article appears on FDA’s Consumer Updates page, which features the latest on all FDA-regulated products.

Date Posted: July 28, 2009