The Centers for Disease Control and Prevention (CDC) reported 10 confirmed cases of infection caused by Burkholderia cepacia complex linked to the use of Medline Remedy Essentials No-Rinse Cleansing Foam. The patients had acquired the infections while hospitalized for acute conditions.
To date, there have been 7 cases reported in Pennsylvania, 2 in California, and 1 in New Jersey.
In March there was a voluntary recall of Medline Remedy Essentials No-Rinse Cleansing Foam (4oz and 8oz) that were positive for presence of B. cepacia. The Food and Drug Administration (FDA) collected samples from a hospital and distribution center which tested positive for B. cepacia; these matched clinical isolates obtained from sick patients by Pulsed Field Gel Electrophoresis (PFGE). Separately, an environmental swab collected at the Company tested positive for a strain of B. cepacia. The FDA is continuing to assess whether other products or lots may pose a risk to consumers.
As a result of the tests, the FDA is advising consumers and clinicians to avoid using all lots of Remedy Essentials No-Rinse Cleansing Foam. In addition to the previously recalled lots (4oz: M06691, M07247 and 8oz: M05703, M06691), the FDA believes additional products may be contaminated.
Any company or hospital in possession of the Medline Remedy Essentials No-Rinse Cleansing Foam should immediately quarantine the product; patients, pharmacies, and all healthcare facilities are recommended to immediately discontinue use and dispensing.
For more information visit FDA.gov.