FDA Warns of No-Rinse Foam After B. cepacia Outbreak 

May 25, 2018

The Food and Drug Administration (FDA) is warning consumers of a multi-state outbreak of Burkholderia cepacia complex, which is also commonly known as Bcc or B. cepacia. The outbreak has been linked to some lots of Medline Remedy Essential No-Rinse Cleansing Foams, which the manufacturer, Shadow Holdings dba Bocchi Laboratories, has since recalled. Products can be recalled for a variety of reasons, including if they pose a threat to consumer health.

This is not the first time the U.S. has been subjected to an outbreak of B. cepacia, which is a type of bacteria that can be found in soil and water. Past outbreaks have been linked to everything from infant supplements, mouthwash, and nasal spray to constipation medications and syringes.

Though most healthy individuals are not harmed by B. cepacia, those with weakened immune systems or certain diseases can develop dangerous infections from the bacteria. Our product liability lawyers explain what you need to know.

FDA Finds 15 Confirmed Cases of B. cepacia Complex

The FDA first learned of this latest B. cepacia outbreak on March 16, 2018, when they were alerted to two clusters of the infection in several states. Working with the Centers for Disease Control and Prevention (CDC) and state-level organizations, the FDA began a thorough investigation that included traceback activities.

Even then the FDA and its partners believed the outbreak could be connected to Medline Remedy Essential No-Rinse Cleansing Foam, which is used in healthcare setting (both hospital and home) as a skin and perineal cleanser for those unable to have traditional baths or showers.

Over time the FDA discovered 15 confirmed cases of B. cepacia—all of which they eventually tied to the use of the Medline Cleansing Foam. There were seven cases of the infection each in California and Pennsylvania and one case in New Jersey. All infected individuals were already hospitalized with acute conditions when they were infected with B. cepacia. 

On March 28, 2018, the CDC began alerting healthcare providers and health officials to the potential risk associated with Medline No-Rinse Cleansing Foam. That same day Shadow Holdings dba Bocchi Laboratories issued an initial voluntary recall of some lots of their Medline Cleansing Foam. They did so after those lots tested positive for the B. cepacia bacteria. On May 8, 2018, they expanded that recall to include another lot of the foam.

How Do I Know If I Am Infected?

One of the challenges with a B. cepacia outbreak is that it can be difficult to diagnose. Some people will show no symptoms at all, while others may experience sudden life-threatening infections. The incubation period can also be drastically different from individual to individual. During that time, it’s possible for the infection to spread to other people.  

Because B. cepacia can be so difficult to identify, it’s important you take action if you believe you may have been exposed to one of the affected lots of Medline No-Rinse Cleansing Foam.

Healthy individuals should not be drastically affected by B. cepacia, but if you were using the foam, it is highly possible you were already suffering from a health condition that may have weakened your immune system. The FDA also says that the fact that the foam in question does not rinse off means there is an increased chance of developing a B. cepacia infection.

If you have chronic lung diseases or chronic granulomatous disease, you may be especially at risk, according to the CDC.

What Products Have Been Recalled?

The following Medline Essentials No-Rinse Cleansing Foam items and lots have been voluntarily recalled by Shadow Holdings dba Bocchi Laboratories due to the possibility of being contaminated with B. cepacia and the potential for severe patient infection:

  • Item number: MSC092FBC04 (4 oz. foam) in lots M06691, M07247, M05703 and M05703

  • Item number: MSC092FBC08 (8 oz. foam) in lots M05703, M06691and M07476

It is likely that Medline Essential No-Rinse Cleansing Foam will have been used on you by a healthcare professional and that you may not know the item or lot number nor have access to the packaging to confirm that information. If that is the case, contact your healthcare provider.

Medline Addresses B. cepacia Outbreak

Blair Klein, a spokesperson for Medline, wrote to Drugwatch to address the outbreak and recall. Klein said the company is working along with the FDA and said that the infected lots came from a contract manufacturer’s facility.

“During the investigation, we tested samples from every lot produced in the affected timeframe,” Klein said. “The results of the testing indicated no contamination in any sample other than the three previously recalled lots. However, out of an abundance of caution and in collaboration with the FDA, we are voluntarily recalling the product. Additionally, to ensure customer certainty and minimize possible confusion, we are halting all shipments of the Remedy Essential No Rinse Foaming Cleanser until further notice.”

I Have Been Affected by a Recalled Product, What’s Next?

Both the FDA and CDC say that B. cepacia is often resistant to common antibiotics and that each case should be treated individually by healthcare professionals. Because of this, it is incredibly important that you contact your healthcare professional if you believe you have been exposed to the affected products.

If you believe you’ve been affected by the B. cepacia outbreak, you may also have legal options to pursue. You can discuss them with a Cutter Law attorney through a free case evaluation.

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