Recall Alert: Hydrogel For Skin Irritations Recalled Because Of Bacteria Contamination

A Texas-based company has recalled its hydrogel product because of bacterial contamination. The recalled product, contaminated with Burkholderia cepecia (B. cepacia) bacteria, can lead to skin infections and it can even cause life-threatening conditions in immunocompromised people.

MPM Medical issued a voluntary recall of one lot of Regenecare HA Hydrogel, an over-the-counter product that can be topically applied "for the temporary relief of pain and itching" related to scrapes, sunburn, insect bites, minor burns and skin irritation. In an announcement posted on the U.S. Food and Drug Administration's (FDA) website, the company said it learned of the B. cepacia contamination after receiving two customer complaints regarding a "visible contamination."

According to the Centers for Disease Control and Prevention (CDC), B. cepacia is the name used for a group of bacteria found in soil and water that are typically resistant to antibiotics. Although they pose "little medical risk" to people considered healthy, immunocompromised patients, such as those undergoing chemotherapy or those with cystic fibrosis, are more susceptible to B. cepacia infections, the CDC said.

The company said using a contaminated product may result in skin infections that may be worse in the case of immunocompromised patients. In them, the infection could spread to the bloodstream, causing "life-threatening" sepsis.

So far, no illnesses related to the product have been reported. The company said it has already notified its customers and distributors.

The recalled product has the lot number 41262, drug code # 66977-107-03 and expiry date "2021-01." It was packed in 3-ounce blue plastic tubes that are sold in boxes of 12. It was distributed nationwide to wholesalers and healthcare facilities.

Customers or healthcare facilities that have the recalled product should stop using the product and dispose of it. Those with questions about the recall can contact MPM Medical at 1-800-232-5512.

"MPM Medical is committed to delivering safe, fully compliant products of the highest quality and is taking necessary steps to prevent future occurrence of this issue," the company said.