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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.

 

Woodridge Labs Recalls Certain DermaFreeze365 Products Because of Possible Health Risk

 

Contact:
Woodridge Labs
818-902-5537

 

FOR IMMEDIATE RELEASE -- Panorama City, CA – March 23, 2007 – Woodridge Labs, Inc., has voluntarily recalled all lots of its 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. This recall was a result of certain limited lots testing positive for the Pseudomonas aeruginosa bacteria.

The organism, Pseudomonas aeruginosa may cause serious eye infections, urinary tract infections, respiratory system infections, dermatitis, soft tissue infections, bacteremia, bone and joint infections, gastrointestinal infections and a variety of systemic infections, particularly in patients with severe burns and in cancer and AIDS patients who are immunosuppressed. Pseudomonas aeruginosa infection is a serious problem in patients hospitalized with cancer, cystic fibrosis, and burns. Because the DermaFreeze365™ Instant Line Relaxing Formula may be applied 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 and, in rare circumstances, possibly blindness.

No illnesses have been reported to date in connection with this problem.

This issue was discovered during the routine product testing process. Woodridge Labs notified its retailers and distributors and the U.S. Food and Drug Administration 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. Woodridge Labs believes that the affected products contain a discoloration that is visible to the naked eye.

Woodridge Labs is working with the third party manufacturer of the affected products to identify the source of the contamination in order to ensure that new lots of DermaFreeze365™ Instant Line Relaxing Formula and DermaFreeze365™ Neck & Chest products will be safe for future use.

Consumers that have the product should discontinue use of the product and destroy it immediately, 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 818-902-5537 or email to recall@woodridgelab.com. This recall is being made in cooperation with the U.S. Food and Drug Administration.

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