Outbreak Update from FDA

FDA Investigates Multistate Outbreak of B. cepacia Complex Linked to Medline Remedy Essentials No-Rinse Cleansing Foam May 21, 2018 Update Fast Facts What is the Problem and What is being Done About It? What are the Symptoms of B. cepacia Infection? Who is at Risk? What Specific Products are Being Recalled? What Do Consumers Need To Do? Who Should be Contacted? Additional Information Update May 21, 2018 As of May 21, 2018, CDC reports that there are 15 confirmed cases of the Burkholderia cepacia complex (Bcc) associated with use of Medline Remedy Essentials No-Rinse Cleansing Foam. There are seven cases in Pennsylvania, one case in New Jersey and seven cases in California. These patients were already hospitalized for acute conditions and acquired the infections while hospitalized. Fast Facts The FDA is advising health professionals and consumers to avoid using all lots of Medline Remedy Essentials No-Rinse Cleansing Foam, manufactured by Shadow Holdings dba Bocchi Laboratories at this time, as these products might be contaminated with the bacteria Burkholderia cepacia complex (Bcc). Shadow Holdings dba Bocchi Laboratories has recalled certain lots of the product. The FDA is investigating whether other products manufactured by Shadow Holdings dba Bocchi Laboratories may be contaminated with, Bcc, and may present a risk to consumers. As of May 21, 2018, CDC reports that there are 15 confirmed cases of Bcc associated with use of Medline Remedy Essentials No-Rinse Cleansing Foam (seven in Pennsylvania, one in New Jersey and seven in California). These patients were already hospitalized for acute conditions and acquired the infections while hospitalized. This cleansing foam is a product used for skin and perineal care. It is used in hospitals and home-health care settings for people who are unable to shower or bathe after surgery or due to other acute health conditions. FDA is particularly concerned about contamination in this product, since product instructions do not include rinsing the product from patient skin. This poses a risk to persons who might be immunocompromised or have other underlying medical conditions. State and federal health officials have collected samples of the product from multiple locations, including affected hospitals. As of May 7, 2018, there have been multiple product samples that tested positive for Bcc. Isolates from these product samples match clinical strains isolated from case patients by Pulsed Field Gel Electrophoresis (PFGE). Additionally, an environmental swab collected at Shadow Holdings, dba Bocchi Laboratories during FDA’s investigation has tested positive for a strain of Bcc. Given these positive samples, the FDA is advising the public to not use any Medline Remedy Essentials No-Rinse Cleansing Foam products at this time. The FDA will update the public with more information as it becomes available. back to top What is the Problem and What is being Done About It? CDC reports that there are 15 confirmed cases of infection caused by bacteria within the Burkholderia cepacia complex, also commonly called Bcc, in three states: California (7), 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 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. The FDA is currently investigating this matter further to determine whether any additional products or lots may present a risk to consumers. Because FDA's investigation is ongoing, the FDA is advising health professionals and consumers to avoid using all lots of Medline Remedy Essentials No-Rinse Cleansing Foam at this time, as this product may be contaminated with Bcc and there is a potential for severe patient infection. Samples of the product that were collected by FDA from a hospital and distribution center tested positive for Bcc; isolates from these samples match clinical 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 has tested positive for a strain of Bcc. The FDA is currently investigating this matter further to determine whether any additional products or lots may present a risk to consumers. Health care professionals and patients should discard all recalled lots of Remedy Essentials No-Rinse Cleansing Foam. As the investigation continues, additional lots and additional products might be identified as potentially harmful. In the interim, facilities should avoid using all other lots of this product, particularly in patients at greater risk for Bcc, until further information is available. Any hospital or company that purchased Medline Remedy Essentials No-Rinse Cleansing Foam should immediately quarantine material under their control and contact Shadow Holdings dba Bocchi Laboratories. Patients, pharmacies, hospitals, and home health care facilities should immediately stop using and dispensing Medline Remedy Essentials No-Rinse Cleansing Foam. FDA will continue to work with CDC and state and local health departments in affected states to gather additional information. back to top What are the Symptoms of B. cepacia Infection? The effects of Bcc infections on people vary widely, ranging from no symptoms at all to life-threatening infections. Strains of Bcc bacteria are often resistant to common antibiotics. Transmission of Bcc from contaminated medicines and devices has been reported. Bcc can also be spread to susceptible persons by: person-to-person contact, contact with contaminated surfaces, or exposure to Bcc in the environment. The incubation period varies. Who is at Risk? Bcc poses little medical risk to healthy people. However, people who have certain health problems, such as weakened Bcc poses little medical risk to healthy people. However, people who have certain health problems, such as weakened immune systems or chronic lung diseases, and chronic granulomatous disease, or wound infections might be more susceptible to infections with Bcc. It’s also important to note that an over the counter cleansing product that does not rinse off, such as this one, increases the likelihood of acquiring an infection, especially among hospitalized patients who might be immunocompromised. Bcc is a known cause of infections in hospitalized patients. Bcc can be resistant to many common antibiotics. Decisions on the treatment of infections with Bcc should be made on a case-by-case basis. back to top What Specific Products are Being Recalled? The following Medline Essentials No-Rinse Cleansing Foam items and lot numbers were voluntarily recalled by Shadow Holdings dba Bocchi Laboratories on March 28, 2018: 4oz Item number MSC092FBC04; lots M06691, M07247; 8oz Item number MSC092FBC08; lots M05703 and M06691, as these products may be contaminated with the bacteria Bcc and there is a potential for severe patient infection. What Do Consumers Need To Do? The FDA is advising health professionals and consumers to avoid using all lots of Medline Remedy Essentials No-Rinse Cleansing Foam at this time. The following item and lot numbers were voluntarily recalled by Shadow Holdings dba Bocchi Laboratories on March 28, 2018: 4oz Item number MSC092FBC04; lots M06691, M07247; 8oz Item number MSC092FBC08; lots M05703 and M06691, as these products may be contaminated with the bacteria Bcc and there is a potential for severe patient infection. Given this is an ongoing investigation, additional products from Shadow Holdings dba Bocchi Laboratories might be contaminated as well. Any hospital or company that purchased Medline Remedy Essentials No-Rinse Cleansing Foam should immediately quarantine material under their control and contact Shadow Holdings dba Bocchi Laboratories. Patients, pharmacies, home health care facilities, hospitals and all health care facilities should immediately stop using and dispensing Medline Remedy Essentials No-Rinse Cleansing Foam. Healthcare facilities should follow the recall instructions for the recalled lots and avoid the use of all other lots of the product while further investigation is being conducted. Evaluation of additional lots is ongoing. In the interim, hospital and health care facilities should avoid using all other lots of this product, particularly in patients at greater risk for Bcc infection, until further information is available. back to top Who Should be Contacted? Report adverse reactions or quality problems experienced with the use of this product to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Additional Information CDC: Multistate Outbreak of Burkholderia cepacia Complex Infections Associated with the Use of Medline Remedy Essentials No-Rinse Cleaning Foam CDC Burkholderia cepacia in Healthcare Settings Medline Canada, Corp. recalls Remedy Essentials Foaming Cleanser