Specific limited lots of Woodridge Labs Inc.'s DermaFreeze365 Instant Line Relaxing Formula (UPC Codes 6-05923-36501-6, 6-05923-36502-3 and 6-05923-10563-6) and DermaFreeze365 Neck & Chest (UPC Code 6-05923-36503-0) products tested positive for the Pseudomonas aeruginosa bacteria, thus prompting their recall. The company notified its retailers and distributors and the US Food and Drug Administration (FDA) on March 13, 2007, and is in the process of implementing a full retail/pharmacy recall of the affected products Nationally and from its distributor in Canada.
The organism, P. aeruginosa, can cause serious eye, urinary tract and respiratory system infections; dermatitis; soft tissue infections, bacteremia; and bone and joint , gastrointestinal and a variety of other systemic infections--particularly in patients with severe burns and in cancer and AIDS patients who are immunosuppressed. According to the FDA, P. aeruginosa infection is a serious problem in patients hospitalized with cancer, cystic fibrosis and burns.
Because the line-relaxing formula may be applied in the area of the eye, there is a possibility that introduction of the tainted product directly in the eye could result in serious eye infections and, in rare circumstances, possibly blindness, reported the FDA. No illnesses have been reported to date in connection with this problem. Woodridge Labs believes that the affected products contain a discoloration that is visible to the naked eye.The company is working with the third party manufacturer of the affected products to identify the source of the contamination in order to ensure that new product lots will be safe for future use.
Consumers that have the product should discontinue use of the product and destroy it immediately, says the FDA, or return it to their place of purchase for further processing. Consumers who have used the product and have concerns should consult a healthcare professional. Consumers with questions regarding the recall may contact Woodridge Labs Inc. at 1-818-902-5537 or e-mail: [email protected].
This issue was discovered during the routine product testing process and is a harsh reminder of the importance of testing products, as well as choosing the right preservative. The Cosmetic, Toiletry and Fragrance Association (CTFA) recently requested public comment on two new microbiology guidelines regarding testing of atypical personal care products, and a rapid method for preservation testing of water-miscible personal care products. Additional preservative literature abounds in the personal care industry; click here for more information.
