FDA Investigates Multistate Outbreak of B. cepacia Complex Linked to Medline Remedy Essentials No-Rinse Cleansing Foam (FDA Announcement)

CDC reports that there are 10 confirmed cases of infection caused by bacteria within the Burkholderia cepaciacomplex, also commonly called B. cepacia, in three states: California (2), Pennsylvania (7), and New Jersey (1). These patients were already hospitalized for acute conditions and acquired the infections while hospitalized. The infections have been linked to the Medline product, Remedy Essentials No-Rinse Cleansing Foam.

On March 28, 2018, Shadow Holdings dba Bocchi Laboratories of Santa Clarita, CA, announced a voluntary recallof 4oz and 8oz bottles of Medline Remedy Essentials No-Rinse Cleansing Foam lots that had been identified as positive for B. cepacia, including lot numbers: M05703, M06691, and M07247. The FDA is currently investigating this matter further to determine whether any additional products or lots may present a risk to consumers.