Food

FDA Investigates Multistate Outbreak of B. cepacia Complex Linked to Medline Remedy Essentials No-Rinse Cleansing Foam

May 25, 2018

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Update 

The U.S. Food and Drug Administration along with the Centers for Disease Control and Prevention (CDC) and state and local officials are investigating a multistate outbreak of B. cepacia infections linked to Medline Remedy Essentials No-Rinse Cleansing Foam.

May 25, 2018 Update:

On May 8, 2018, Shadow Holdings dba Bocchi Laboratories expanded their recall to include additional products, including an additional lot of Medline Remedy Essentials No-Rinse Cleansing Foam.

The FDA is currently advising health professionals and consumers to avoid using products that have been recalled by Shadow Holdings dba Bocchi Laboratories, as these products may be contaminated with the bacteria Burkholderia cepacia complex (Bcc). The FDA is particularly concerned about potential contamination in recalled lots of Medline Remedy Essentials No-Rinse Cleansing Foam, since laboratory analysis by the FDA confirmed that samples of this product contained Bcc matches Bcc isolates collected from the Shadow Holdings dba Bocchi Laboratories facility and from ill persons. The matches were detected by pulsed field gel electrophoresis (PFGE), a type of DNA fingerprinting. Shadow Holdings dba Bocchi Laboratories has recalled other products made in the same location.

Fast Facts

  • The FDA is advising health professionals and consumers to avoid using products that have been recalled by Shadow Holdings dba Bocchi Laboratories as they might be contaminated with bacteria within the Burkholderia cepacia complex, also commonly called Bcc.
  • The FDA is particularly concerned about potential contamination in recalled lots of Medline Remedy Essentials No-Rinse Cleansing Foam, since laboratory analysis by the FDA confirmed that samples of this product containing Bcc from the Shadow Holdings dba Bocchi Laboratories facility matches Bcc isolates collected from ill persons by Pulsed Field Gel Electrophoresis (PFGE), a type of DNA fingerprinting. Shadow Holdings dba Bocchi Laboratories has recalled other products made in the same location. 
  • On May 8, 2018, Shadow Holdings dba Bocchi Laboratories expanded their recall to include additional products, including an additional lot (M07476) of Medline Remedy Essentials No-Rinse Cleansing Foam. The recalled lot numbers for Medline Remedy Essentials No-Rinse Cleansing Foam include: M05703, M06691, M07247, and M07476.
  • The FDA is investigating whether other products manufactured by Shadow Holdings dba Bocchi Laboratories may be contaminated with Bcc and 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 California, one in New Jersey, and seven in Pennsylvania). 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. The 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.
  • The FDA will update the public with more information as it becomes available.

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Timeline

On March 16, 2018, the FDA learned about two clusters of the Burkholderia cepacia complex (Bcc) infections currently being investigated in multiple states that may be associated with exposure to Medline Remedy Essentials No-Rinse Cleansing Foam products.

In the following weeks, the FDA, CDC, and state partners worked together to collect additional information and conduct traceback activities.

On March 26, 2018, FDA began collecting samples of the Medline Remedy Essentials No-Rinse Cleansing Foam product from hospitals and distribution centers, some of which later tested positive for Bcc.

On March 28, 2018, CDC posted on the Epidemic Information Exchange (Epi-X), which is widely distributed among local, state, and federal health officials, naming the Medline No-Rinse Cleansing Foam product and asking facilities to alert CDC of illnesses.

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.

On April 13, 2018, CDC updated the Epi-X with an addendum to include reference to the recalled product.

On May 4, 2018, laboratory analysis of samples collected by FDA confirmed that the Medline Remedy Essentials No Rinse Cleansing-Foam sample containing Bcc from the Shadow Holdings dba Bocchi Laboratories facility matches Bcc 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 was positive for a strain of Bcc.

On May 8, 2018, the FDA advised health professionals and consumers to avoid using all Medline No-Rinse Cleansing Foam products manufactured by Shadow Holdings dba Bocchi Laboratories, as these products might be contaminated with Bcc.

On May 8, 2018, Shadow Holdings dba Bocchi Laboratories, expanded their recall to include additional products, including an additional lot of Medline Remedy Essentials No-Rinse Cleansing Foam. Given this newly expanded recall, the FDA is currently advising health professionals and consumers to avoid using avoid using the recalled products, particularly the recalled lots of Medline No-Rinse Cleansing Foam: M05703, M06691, M07247, and M07476.

What is the Problem and What is being Done About It?

As of May 21, 2018, CDC reports that there are 15 confirmed cases of infection caused by bacteria within the Burkholderia cepacia complex (Bcc), in three states: California (7), New Jersey (1), and Pennsylvania (7). 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.

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.

On May 8, 2018, Shadow Holdings dba Bocchi Laboratories expanded their recall to include additional products, including an additional lot of Medline Remedy Essentials No-Rinse Cleansing Foam. The FDA is advising health professionals and consumers to avoid using the recalled lots of Medline Remedy Essentials No-Rinse Cleansing Foam (M07476, M06691, M07247, and M05703), as these products may be contaminated with Bcc and there is a potential for severe patient infection.

Health care professionals and patients should discard all recalled lots of Remedy Essentials No-Rinse Cleansing Foam. Any hospital or company that purchased recalled 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 with lot numbers: M05703, M06691, M07247, and M07476.

The FDA is currently investigating this matter further to determine whether any additional products or lots may present a risk to consumers. FDA will continue to work with CDC and state and local health departments in affected states to gather additional information.

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What are the Symptoms of Bcc Infection?

The incubation period and effects of Bcc infection on people can 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.

Who is at Risk?

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 the Medline Remedy Essentials No-Rinse Cleansing Foam, 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.

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What Specific Products are Being Recalled?

On March 28, 2018, the following Medline Essentials No-Rinse Cleansing Foam items and lot numbers were voluntarily recalled by Shadow Holdings dba Bocchi Laboratories: 4oz Item number MSC092FBC04; lots M06691, M07247 and M05703; 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.

On May 8, 2018, Shadow Holdings dba Bocchi Laboratories expanded their recall to include additional products, including an additional lot 8oz Item number MSC092FBC08 Medline Remedy Essentials No-Rinse Cleansing Foam: M07476 and 4oz Item number MSC092FBC04 of lot M05703.

For a list of all recalled products, search Shadow Holdings dba Bocchi Laboratories under Recalling Firm: https://www.accessdata.fda.gov/scripts/ires/index.cfm.

What Do Consumers Need To Do?

FDA is currently advising health professionals and consumers to avoid using products that have been recalled by Shadow Holdings dba Bocchi Laboratories, and recalled lots of Medline No-Rinse Cleansing Foam in particular. The following item and lot numbers of Medline No-Rinse Cleansing Foam were voluntarily recalled by Shadow Holdings dba Bocchi Laboratories on March 28, 2018 and May 8, 2018: 4oz Item number MSC092FBC04, lots M06691, M07247 and M05703; 8oz Item number MSC092FBC08, lots M05703, M07476, and M06691; as these products may be contaminated with the bacteria Bcc and there is a potential for severe patient infection.

Any hospital or company that purchased recalled 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 recalled 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.

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Who Should be Contacted?

Report adverse reactions or quality problems experienced with the use of products manufactured by Shadow Holdings dba Bocchi Laboratories to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

Additional Information

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Page Last Updated: 05/25/2018
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