Pharmaceutical

FDA warns about possibly contaminated cleansing foam

foam cleanser pump 315x210 FDA warns about possibly contaminated cleansing foamAvoid using Medline Remedy Essentials No-Rinse Cleansing Foam manufactured by Shadow Holdings, doing business as Bocci Laboratories, until further notice. The products may be contaminated with several species within the bacteria Burkholder cepacia complex (Bcc), and pose risks to patients with compromised immune systems.

As of May 2018, the Centers for Disease Control and Prevention (CDC) has confirmed 10 cases of Bcc linked to use of Medline Remedy Essentials No-Rinse Cleansing Foam – seven in Pennsylvania, one in New Jersey, and two in California. The patients were already hospitalized for acute conditions and acquired the infections while in the hospital.

The cleansing foam is used to clean skin and the perineal area. The products are used in hospitals and home-health care settings for patients who are unable to shower or bathe after surgery or due to acute health conditions. What is particularly concerning about the potential for the foam to be contaminated is that it is not intended to be rinsed from the skin.

State and federal health officials have collected samples of the Medline Remedy Essentials No-Rinse Cleansing Foam from multiple locations, including hospitals where patients became infected. As of May 7, 2018, several samples have tested positive for Bcc.

In March, Shadow Holdings/Bocchi Laboratories conducted a voluntary recall of specific lots of 4 oz and 8 oz bottles of Medline Remedy Essentials No-Rinse Cleansing Foam that had been identified as positive for Bcc. The FDA is further investigating to determine whether any additional products or lots may present a risk to consumers. In the meantime, health care professionals and consumers are advised not to use any lots of the cleansing foam until further notice.

The effects of Bcc infection vary widely among people ranging from no symptoms to life-threatening infections. Bcc bacteria are often resistant to common antibiotics.

Any infections related to use of this cleansing foam should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch/Report.htm.

Source: FDA Safety Communication