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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.

 

FiberChoice Plus Multivitamins Issues Allergy Alert Fish Allergen Not Declared on Label

 

Contact:
GlaxoSmithKline Consumer Healthcare
1-800-819-0681

 

FOR IMMEDIATE RELEASE -- Pittsburgh, PA -- March 20, 2007 -- GlaxoSmithKline (GSK) Consumer Healthcare, marketers of FiberChoice® fiber supplement is recalling the newest variant of FiberChoice® plus Multivitamins fiber supplement. This recall affects 90 count (16oz.) plastic bottles with the UPC #5714500581, which is located on the side of the bottle in black lettering. One of the following lot numbers appears on the bottom of the bottle in black lettering:

06L06207A00807A07307A120
06L06307A00907A07487673901 (display)
06L10207A05107A075 
06M07507A05207A076 
07A00107A05307A077 
07A00207A05407A078 
07A00307A05507A080 
07A00407A06807A116 
07A00507A06907A117 
07A00607A07007A118 
07A00707A07207A119 

This recall was initiated after we discovered fish gelatin, a known allergen, contained in one of the raw materials of the product, which was not declared on the product label for the multivitamins being recalled. The fish gelatin consists of the following species of fish: cod, pollock, hake, cusk, haddock, redfish, sole, and flounder.

No other FiberChoice fiber supplement products are affected by this recall.

To date, there have been no reports of adverse reactions due to fish allergies with this specific product. There is a possible health risk to consumers with both known and previously unknown fish allergies. Consumers with fish allergy sensitivities run the risk of a serious or life threatening allergic reaction if they consume the product and should not take this product. If consumers experience a reaction after ingesting this product, they should seek medical attention.

The health and safety of our consumers is of utmost importance, and we would like to assure consumers that GSK Consumer Healthcare is working to correct this allergen labeling omission.

PLEASE NOTE: GSK Consumer Healthcare estimates the recall involves approximately 144,000 plastic bottles. This product was recently shipped to major retailers, including food and drug and mass merchandisers beginning on January 15, 2007.

Consumers who have purchased the new FiberChoice plus Multivitamins fiber supplement should return it to the retail store where it was purchased for a full refund. Consumers with questions about the product or this recall are encouraged to call GlaxoSmithKline Consumer Healthcare toll-free at 1-800-819-0681.

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