FDA is advising consumers and health care providers against using Medline Remedy Essentials No-Rinse Cleansing Foam skin care product that was recalled in late March after the agency determined potential contamination with Burkholderia cepacia complex bacteria. The product, marketed by Medline Industries Inc.to health care facilities and providers and to consumers, was recalled by manufacturer Bocchi Laboratories Inc., a subsidiary of Shadow Holdings LLC in Santa Clarita, Calif. (Also see "Jason Mouth Rinse Among Recent Health And Wellness Product Recalls" - HBW Insight, 20 April, 2018.) FDA on May 9 said the recall remains limited to the 4- and 8-ounce packages of the product listed when Bocchi Labs announced the recall, but it is "investigating this matter further to determine whether any additional products or lots may present a risk to consumers."
The agency announced that the Centers for Disease Control and Prevention has reported 10 confirmed cases of B. cepacian infection linked to the product in three states: one in New Jersey, two in California and seven in Pennsylvania. The patients acquired the infections after they were hospitalized. Samples of the product collected by FDA from a hospital and a distribution center tested positive for B