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U.S. Department of Health and Human Services

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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Eco Health, Inc Recalls Product Because Of Possible Health Risk 

Contact:
Consumer:
1-661-208-3446
 

FOR IMMEDIATE RELEASE - September 4, 2012 - ECO HEALTH, INC of Chatsworth, CA is recalling its florAlign PREBIOTIC FORMULA (POWDER) in the following quantities; 

 60 units of the 90 gram PREBIOTIC FORMULA (powder),
 40 units of the 180 gram PREBIOTIC FORMULA (powder) and
 174 units of the 270 gram PREBIOTIC FORMULA (powder)

This PREBIOTIC FORMULA was marketed under the name florAlign PREBIOTIC FORMULA.  (Please note that this recall does not effect the ECO HEALTH, INC PROBIOTIC FORMULA which is a capsule marketed also under the FlorAlign Label). 

The PREBIOTIC FORMULA ONLY is being recalled 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 circumstances, 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.

The florAlign PREBIOTIC FORMULA was distributed within the United States (throughout the nation) via direct to consumer marketing (mail order, internet and direct delivery).

The PREBIOTIC FORMULA was distributed in three sizes (90 gram, 180 gram, and 270 grams).  UPC code #'s FA02-90GM, FA02-180GM, and FA02-270GM respectively. It is a berry flavored powder in a white plastic screw off container and contains a scooper.  It is distributed by Eco-Health, Inc. and contains the following address on the label.  25876 The Old Road #158, Newhall, CA 91321.  The dates of distribution are between June 2011 - Aug 2012 in the quantities mentioned above.

There are specific instructions on the label to report any adverse effects to the above address.
No illnesses have been reported to date.

This possible problem was first brought to the attention of ECO-HEALTH, INC via the FDA because the contract manufacturer notified the FDA of a similar problem with the Ingredion label.  The product was manufactured by Northridge Labs which is owned by Irwin Naturals.  The company has ceased the production and distribution of the product as the company continues their investigation as to what caused the problem.

Customers can call our customer service department with any questions and are urged to return the product for a full refund. Consumers with questions may contact the company at 1-661-208-3446 between 7am and 7pm PST Monday thru Friday.


 

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