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FOR IMMEDIATE RELEASE P-01-13 June 8, 2001 |
Print Media 202-205-4144 Consumer Inquiries 888-INFO-FDA |
The FDA is warning consumers not to purchase or use Pierre Fabre Physicians Formula Eye Makeup Remover Lotion because it may be contaminated with Pseudomonas fluorescens and/or Pseudomonas putida, bacteria that can cause severe, sight-threatening infections of the cornea. The manufacturer, Physicians Formula Cosmetics of Azusa, California, a subsidiary of Pierre Fabre, Inc. is voluntarily recalling 16,300 bottles of the product.
This product was distributed nationwide through retail stores, pharmacies, and supermarkets from March 14 though May 28, 2001.
This product is sold in 2 oz. bottles with #698 the on the back of the label and batch numbers #0821 or #0601 imprinted on the bottom of the bottle. No injuries or adverse events have been reported to date in connection with this problem.
The recall was the result of a routine sampling program by the company which revealed that the finished products contained the bacteria.
Consumers who have used this product should contact their physician if they experience any problems with their eyes. Individuals who have purchased Physicians Formula Eye Makeup Remover Lotion are urged to return it to the place of purchase for a full refund. Consumers with questions may contact the company at 1-800-227-0333.
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This is a mirror of the page at http://www.fda.gov/bbs/topics/NEWS/2001/NEW00763.html