FDA: Skin cleansing foam recalled over bacteria concern

Health care professionals and consumers are being told to stop using a brand of a skin cleansing foam because it may be contaminated with bacteria.

The Food and Drug Administration has issued an advisory warning against the use of Medline Remedy Essentials No-Rinse Cleansing Foam.

The FDA says the product manufactured by Shadow Holdings dba Bocchi Laboratories might contain several species within the bacteria known as Burkholderia cepacia complex, or Bcc.

The effects of B. cepacia infection on people vary widely, ranging from no symptoms at all to life-threatening infections. It can also be spread to susceptible persons by: person-to-person contact, contact with contaminated surfaces, or exposure to B. cepacia in the environment. The incubation period varies.

Experts say B. cepacia 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 B. cepacia.

According to the FDA, an over the counter cleansing product such as this on that does not rinse off, increases the likelihood of acquiring an infection, especially among hospitalized patients who might be immunocompromised.

B cepacia is a known cause of infections in hospitalized patients and can be resistant to many common antibiotics.

As of Monday, CDC reported 10 confirmed cases of Bcc associated with use of Medline Remedy Essentials No-Rinse Cleansing Foam.

Seven cases were reported in Pennsylvania, one in New Jersey and two 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.

Shadow Holdings dba Bocchi Laboratories has recalled certain lots of the product.

Healthcare professionals and patients should discard all recalled lots of Remedy Essentials No-Rinse Cleansing Foam.

The FDA says as the investigation continues, additional lots and additional products might be identified as potentially harmful.

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.