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DermaFreeze365 Recall

DermaFreeze365 has been recalled because it may be contaminated with Pseudomonas aeruginosa, a bacteria that can cause serious infections.  If you have been using DermaFreeze365™ Instant Line Relaxing Formula and have contracted an infection, contact Pritzker | Ruohonen regarding a lawsuit against the manufacturer.  1-888-377-8900 (toll-free) or submit the firm's online consultation form.
   
Our senior partner, Fred Pritzker, has over 30 years of product liability lawsuit experience and has recovered millions for clients.  In addition to his many other accomplishments, he is a member of the Million Dollar Advocates Forum and a Certified Trial Specialist.  In recognition of his accomplishments, he has been selected by other lawyers for inclusion in The Best Lawyers in America.

FDA Recall Announcement: Woodridge Labs Recalls Certain DermaFreeze365 Products Because of Possible Contamination with Pseudomonas Aeruginosa

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.

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.

Types of Infection Caused by Pseudomonas aeruginosa
The bacteria Pseudomonas aeruginosa can cause infections that may result in serious injury or death.   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.

The infections that can be caused by Pseudoomonas aeruginosa include the following:

  • Bloodstream infections
  • Bone and joint infections
  • Eye Infections
  • Respritory system infections, including pneumonia (lung infection)
  • Skin infections
  • Urinary tract infections

Death from Infection Associated with Pseudomonas aeruginosa 
People who are immunocompromised, such as those with AIDS, cancer, cystic fibrosis or severe burns, are particularly susceptible to Pseudomonas aeruginosa-related infections, and the fatality rate can be high with this group:

  • In the AIDS population, P. aeruginosa is associated with a 50% death rate.
  • In certain cancer patients, the death rate from pneumonia caused by P. aeruginosa is 30%.
  • P. aeruginosa outbreaks in burn units have had 60% death rates.

References:

  1. Bergen GA, Shelhamer JH. Pulmonary infiltrates in the cancer patient. Infect Dis Clin North Am 1996;10:297-326.
  2. Dunn M, Wunderink RG. Ventilator-associated pneumonia caused by Pseudomonas infection [review]. Clinics in Chest Medicine 1995;16:95-109.
  3. Richard P, Le FR, Chamoux C, Pannier M, Espaze E, Richet H. Pseudomonas aeruginosa outbreak in a burn unit: role of antimicrobials in the emergence of multiply resistant strains. J Infect Dis 1994;170:377-83.
  4. Mendelson MH, Gurtman A, Szabo S, Neibart E, Meyers BR, Policar M, et al. Pseudomonas aeruginosa bacteremia in patients with AIDS [review]. Clin Infec Dis 1994;18:886-95.
  5. Govan JR, Deretic V. Microbial pathogenesis in cystic fibrosis: mucoid Pseudomonas aeruginosa and Burkolderia cepacia. Microbiol Rev 1996;60:539-74.
  6. Van Delden C, Igewski B. Cell-to-Cell Signaling and Pseudomonas aeruginosa Infections. Emerging Infectious Diseases 1998; 4. http://www.cdc.gov/ncidod/eid/vol4no4/vandelden.htm.


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