The U.S. Food & Drug Administration (FDA) is investigating a rare outbreak of Burkholderia cepacia complex bacteria, also known as B. cepacia, associated with Medline Remedy Essentials No-Rinse Cleansing Foam.
Free Confidential Class Action Lawsuit Evaluation: If you or a loved one has been diagnosed with a B. cepacia infection, you should contact our law firm immediately. You may be entitled to compensation by filing a lawsuit and our lawyers can help.
What’s the problem?
May 25, 2018 – As of Monday, the U.S. Centers for Disease Control and Prevention (CDC) reports at least 10 confirmed cases of B. Cepacia (7 in Pennsylvania, 1 in New Jersey, 2 in California) linked to Medline Remedy Cleansing Foam, according to an FDA Safety Alert issued on Tuesday. All 10 patients were already hospitalized for acute conditions and acquired the B. cepacia infections while hospitalized, the agency said.
What is B. Cepacia?
Burkholderia cepacia, a bacteria formerly known as Pseudomonas cepacia, is a rare but significant health threat to people with chronic diseases or other conditions that result in weakened immune systems, according to the Cystic Fibrosis Foundation. B. cepacia bacteria are notoriously difficult to attack due to its natural multi-drug resistant state and its quick ability to develop resistance to antibiotics. Infections with B. cepacia are often asymptomatic, but when symptoms do present, they may include:
- Fever
- Cough
- Congestion
- Shortness of breath
- Wheezing
Medline Foaming Cleanser Recall Timeline
On March 16, 2018, the FDA learned about two clusters of the Burkholderia cepacia complex (Bcc) infections currently being investigated in multiple states that may be associated with exposure to Medline Remedy Essentials No-Rinse Cleansing Foam products.
In the following weeks, the FDA, CDC, and state partners worked together to collect additional information and conduct traceback activities.
On March 26, 2018, FDA began collecting samples of the Medline Remedy Essentials No-Rinse Cleansing Foam product from hospitals and distribution centers, some of which later tested positive for Bcc.
On March 28, 2018, CDC posted on the Epidemic Information Exchange (Epi-X), which is widely distributed among local, state, and federal health officials, naming the Medline No-Rinse Cleansing Foam product and asking facilities to alert CDC of illnesses.
On March 28, 2018, Shadow Holdings dba Bocchi Laboratories of Santa Clarita, CA, announced a voluntary recall of 4oz and 8oz bottles of Medline Remedy Essentials No-Rinse Cleansing Foam lots that had been identified as positive for Bcc, including lot numbers: M05703, M06691, and M07247.
On April 13, 2018, CDC updated the Epi-X with an addendum to include reference to the recalled product.
On May 4, 2018, laboratory analysis of samples collected by FDA confirmed that the Medline Remedy Essentials No Rinse Cleansing-Foam sample containing Bcc from the Shadow Holdings dba Bocchi Laboratories facility matches Bcc isolates collected from ill persons by Pulsed Field Gel Electrophoresis (PFGE), a type of DNA fingerprinting. Additionally, an environmental swab collected at Shadow Holdings, dba Bocchi Laboratories during FDA’s investigation was positive for a strain of Bcc.
On May 8, 2018, the FDA advised health professionals and consumers to avoid using all Medline No-Rinse Cleansing Foam products manufactured by Shadow Holdings dba Bocchi Laboratories, as these products might be contaminated with Bcc.
On May 8, 2018, Shadow Holdings dba Bocchi Laboratories, expanded their recall to include additional products, including an additional lot of Medline Remedy Essentials No-Rinse Cleansing Foam. Given this newly expanded recall, the FDA is currently advising health professionals and consumers to avoid using avoid using the recalled products, particularly the recalled lots of Medline No-Rinse Cleansing Foam: M05703, M06691, M07247, and M07476.
Do I Have a B. Cepacia Class Action Lawsuit?
The Product Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus on the representation of plaintiffs in B. Cepacia lawsuits. We are handling individual litigation nationwide and currently accepting new cases in all 50 states.
Free Case Evaluation: Again, if you were infected with B. cepacia bacteria, you should contact our law firm immediately. You may be entitled to a settlement by filing a lawsuit and we can help.