B. cepacia Outbreak Tied to No-Rinse Cleansing Foam

The FDA is advising consumers and clinicians to avoid using all lots of Remedy Essentials No-Rinse Cleansing Foam.
The FDA is advising consumers and clinicians to avoid using all lots of Remedy Essentials No-Rinse Cleansing Foam.

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. 

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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.