FDA MedWatch - Medline Remedy Essentials No-Rinse Cleansing Foam: Avoid Using - Multistate Outbreak of Burkholderia Cepacia Complex

Medline Remedy Essentials No-Rinse Cleansing Foam: Avoid Using - Multistate Outbreak of Burkholderia Cepacia Complex

AUDIENCE: Consumer, Health Professional, Patient

ISSUE: CDC reports that there are 10 confirmed cases of infection caused by bacteria within the Burkholderia cepacia complex, 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.

BACKGROUND: 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 B. cepacia.

Samples of the product that were collected by FDA from a hospital and distribution center tested positive for B. cepacia; 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 B. cepacia. The FDA is currently investigating this matter further to determine whether any additional products or lots may present a risk to consumers.

RECOMMENDATION: 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 B. cepacia 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 healthcare facilities should avoid using all other lots of this product, particularly in patients at greater risk for B. cepacia infection, until further information is available.

Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

Read the MedWatch Safety Alert at: https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm607371.htm