FDA Announces Recall of SimplySmartJan 7, 2009 | Parker Waichman LLP
All lots of Celeste Industries Corporation’s SimplySmart™ “Remove” Make-Up Remover are being recalled in the United States and Canada because of bacterial contamination. The U.S. Food and Drug Administration (FDA) announced that the Celeste SimplySmart™ Remove Make-Up Remover is packaged as a single towelette and that the word “hiexpress.com” appears on the towelette’s package.
The FDA said that Celeste Industries Corporation voluntarily recalled all lots of its SimplySmart™ "Remove" Make Up Remover after a consumer complained of an odor coming from the towelette packets and testing revealed positive results for the Pseudomonas aeruginosa bacteria. The FDA explained that 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. Also, the FDA notes that because the Celeste SimplySmart™ Remove Make-Up Remover may be used in the eye area, it is possible that the bacteria could enter the eye, resulting in serious eye infections.
The Celeste SimplySmart™ Remove Make-Up Remover 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, the FDA said. Celeste Industries Corporation describes itself as being a provider of products to the transportation industry and produces lavatory and cleaning chemicals, hand-care systems, and amenity items to over 100 clients in over 82 countries. The SimplySmart™ “Remove” Make-Up Remover product is one of Celeste’s amenity items. Celeste Industries stopped production of the SimplySmart™ Remove Make-Up Remover on October 5, 2008 and has since identified the source of the contamination.
The FDA is advising hotel guests who may have taken the Celeste SimplySmart™ “Remove” Make-Up Remover product to not use the recalled Celeste Remover and destroy it immediately. The FDA is also advising consumers who have used the recalled make-up remover and who have concerns to contact a healthcare professional.
The FDA has also advised consumers with questions about the recall to contact Celeste Industries Corporation at 410-822-6200, ext 1349 between 8:00 a.m. and 5:00 p.m. EST; ask for the Quality Assurance department. Consumers can also email Celeste Industries at email@example.com. The Celeste Industries Corporation Website is http://www.celestecorp.com/index.html.