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U.S. Food and Drug adminiatration
Easton, Maryland – January 5, 2009 –
Celeste Industries Corporation has voluntarily recalled all lots of simplySmart™ "Remove" Make Up Remover in the US and Canada This product is packaged as a single towelette with hiexpress.com shown on the packet. This recall was a result of certain limited lots testing positive for Pseudomonas aeruginosa bacteria.
The organism Pseudomonas aeruginosa may cause serious eye infections, respiratory infections, dermatitis, soft tissue infections, bacteremia, and a variety of systemic infections, particularly in patients who are immunosuppressed. Because the Make-Up Remover may be used in the area of the eye, there is a possibility that inadvertent introduction of the tainted product directly in the eye could result in serious eye infections.
No illnesses have been reported to date in connection with this problem. The issue was discovered after a consumer complained of an odor coming from the towelette packets.
This product is not sold in the retail market but is provided as a guest amenity at Holiday Inn Express® hotels in the United States in Canada.
Celeste Industries ceased production of the product on October 5, 2008 and subsequently notified the distributor and the Food and Drug Administration
Any hotel guests who may have taken the product are advised to not use the product and to destroy it immediately. Consumers who have used the product and have any concerns should contact a healthcare professional.
Celeste Industries has identified the source of the contamination and will take all necessary steps to prevent future contamination when production of the product is resumed.
Consumers with questions regarding the recall should contact Celeste Industries Corporation at 410-822-6200, ext 1349 between 8:00 a.m. and 5:00 p.m. EST and ask for Quality Assurance or e-mail at firstname.lastname@example.org. This recall is being made in cooperation with the Food and Drug Administration.