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FDA takes action against three supplement companies

News - Health Articles

 

FDA NEWS RELEASE
For Immediate Release: July 10, 2009
FDA Takes Enforcement Action Against Three New Jersey Dietary Supplement and Protein Powder Manufacturers
Companies failed to declare allergens in products and correct filthy conditions
The U.S. Department of Justice, on behalf of the U.S. Food and Drug Administration, has filed a complaint for permanent injunction against Quality Formulation Laboratories, Inc., American Sports Nutrition Inc., Sports Nutrition International LLC and Mohamed S. Desoky, who oversees operations at all three companies

.

The companies, located in Paterson, N.J., manufacture dietary supplements and protein powders and distribute them throughout the United States. The companies also export powder mixes and dietary supplements for sale by private label customers.

The government’s complaint, filed July 1, 2009 in the U.S. District Court of New Jersey, alleges that the companies have failed to follow current Good Manufacturing Practice (GMP) by manufacturing and storing food under filthy conditions and in conditions that may cause major food allergens to enter into products not intended to contain them.

The complaint also alleges that the companies failed to disclose major food allergens on the product labels and have other labeling problems.

During a recent inspection, FDA investigators found that several of the companies’ products contained milk ingredients that were not declared on the product labels. In addition, the company failed to clean processing equipment between batches and control allergens in the facility.

FDA investigators also discovered live and dead rodents and rodent urine, feces and gnaw holes on bags of product.

In three inspections, FDA investigators noted deviations from GMP standards. The companies promised to make corrections, but they failed to do so. The complaint requests a court order to stop the companies and its officer from manufacturing and distributing the products until needed corrections are made.

“This company has consistently failed to correct filthy conditions in their plants and to make sure that allergens are appropriately declared on the labels, despite frequent warnings to do so,” said Michael Chappell, the FDA’s acting associate commissioner for regulatory affairs. “The FDA will not tolerate companies that fail to provide adequate safeguards.”

Consumers with allergies to milk ingredients who have used these products and are experiencing any symptoms should contact their health care professional.

Consumers can report problems with FDA-regulated products to their district office consumer complaint coordinator.


FOR IMMEDIATE RELEASE                      7/7/09
Vital Pharmaceuticals Inc dba VPX Sports
800-954-7904/954-641-0570 

    Vital Pharmaceuticals Inc. RECALLS POWDERED DIETARY SUPPLEMENT, STEALTH CHOCOLATE and STEALTH VANILLA BECAUSE OF POSSIBLE HEALTH RISK

    Vital Pharmaceuticals Inc. of 15751 SW 41st Street #300, Davie, Fl. 33331 is recalling 17 lots of the powdered dietary supplement, Stealth Chocolate and Stealth Vanilla, because it has the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with weakened immune systems.  Healthy persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting and abdominal pain.  In rare circumstance, infection with Salmonella can result in the organism getting into the bloodstream and producing more severe illnesses such as arterial infections (i.e., infected aneurysms), endocarditis and arthritis.

lot #    Product Name    Expiry Date        lot #    Product Name    Expiry Date
SP9118A2    Vanilla    04--11        SP9118B2    Chocolate    04--11
SP9119B2    Vanilla    04--11        SP9119A2    Chocolate    04--11
SP9120A2    Vanilla    04--11        SP9121C2    Chocolate    05--11
SP9120B2    Vanilla    04--11        SP9124A2    Chocolate    05--11
SP9121A2    Vanilla    05--11        SP9124B2    Chocolate    05--11
SP9121B2    Vanilla    05--11        SP127A2    Chocolate    05--11
SP9131A2    Vanilla    05--11        SP127B2    Chocolate    05--11
SP9140A2    Vanilla    05--11               
                       
SP9125A3    Vanilla - 75 g    05--11        SP9126A3    Chocolate - 75 g    05--11
               

 Where the expiry dates represent the month and year.

The UPC is 1076482486 for the Stealth Chocolate (5 lb), 1076482484 for the Vanilla Stealth (5 lb), 1076482498 for the Stealth Chocolate (75g) and 1076482496 for the Stealth Vanilla (75 g).                                
Stealth Vanilla and Stealth Chocolate was distributed Nationwide, including GNC Distribution Centers in Phoenix AZ; in Anderson, SC; and in Leetsdale, PA; and to VPX Sports Distribution Center in Weston, Fl; as well as Internationally.

    The powdered product is packaged in 5lb blue, plastic jars with red band on around the top and bottom of the jar. The principal label bears the brand name of VPX and STEALTH, Muscle Amplification Lean Mass Gainer and the flavor in the lower 1/3; Vanilla Blast or Chocolate Rush. The production code and the expiration date are imprinted on the side panel above the Supplement Facts. The powdered product was also packaged in foil pouches as samples.

    "No illnesses have been reported to date."
   
We are taking this action because our product contains an ingredient Milk Protein Concentrate, recalled by one of our supplier, Plainview Milk Products Cooperative, because it may be contaminated with Salmonella.


    Consumers should return the product to the store where it was purchased for a full refund. Consumers with questions may contact Vital Pharmaceutical Inc. at 1-800-954-7904 or 954-641-0570 during the hours of 9 am – 5 pm, Monday through Friday.
                           


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