Wound Antimicrobial Gel Distributed In 17 States Recalled Over Possible Bacterial Contamination

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FDA Food and Drug
The FDA's headquarters and home of the Center for Drug Evaluation and Research in Silver Spring, Maryland.

A company is recalling one lot of its wound care gel distributed in multiple states because the product may be contaminated with bacteria. Those who use a contaminated product on a wound could develop an infection.

California-based Blaine Labs is recalling its RevitaDerm Wound Care Gel, a skin wound antimicrobial product, after a 1.0-ounce bottle turned out to be contaminated with Bacillus cereus, the company announced on the U.S. Food and Drug Administration's (FDA) website.

B. cereus is a microorganism that's quite widespread in the environment and can commonly be found in the soil, as well as vegetables and raw and processed foods. As a foodborne pathogen, it can produce toxins that cause two types of gastrointestinal illnesses – one that's characterized by diarrhea and another that's characterized by vomiting. In fact, it is said to be a "relatively common" cause of gastroenteritis across the globe.

However, if a product that's contaminated with B. cereus is applied to a wound, it can also develop an infection that leads to serious complications, the company noted. Although such cases among patients who are not immunocompromised are "less severe" and since they respond to treatments well, B. cereus infections among those who are immunocompromised and "preterm neonates" can be invasive and even life-threatening.

Though Blaine Labs has not received reports of adverse events related to the recall so far, it has notified its physician clients of the issue and is arranging for the return of undispensed products. Patients who have an affected product should stop using it and instead, take the remaining unused product back to the physician.

The affected products include the 1.0-ounce bottle and 3.0-ounce tubes of RevitaDerm Wound Care Gel with lot number BL 2844 and the expiration date of 02/19/2023. They were distributed to 61 clinics in 17 states last year.

A photo of the recalled products is available on the FDA's website. Customers who have questions about the recall can contact the company at 800-307-8818 or by email at info@blainelabs.com.

The headquarters of the U.S. Food and Drug Administration (FDA) is seen in Silver Spring, Maryland
The headquarters of the U.S. Food and Drug Administration is seen in Silver Spring, Maryland.
Photo: Reuters

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