Blaine Labs is recalling one lot of RevitaDerm wound care gel over a bottle that was found to be contaminated with Bacillus cereus.
Blaine Labs said Jan. 27 that the affected lot is BL 2844, with an expiration date of Feb. 19, 2023. It was distributed to 61 physician clinics across 17 states in 2021.
Patients who apply the contaminated product to a wound could develop a skin and soft tissue infection, which could lead to serious complications. For immunocompromised patients and premature infants, the bacteria can cause life-threatening infections including wound and blood infections, sepsis, pneumonia and meningitis.
Blaine Labs said it is arranging for the return of undispensed 1-ounce bottles and 3-ounce tubes from the recalled lot. Patients who have the RevitaDerm Wound Care Gel 1-ounce bottles or 3-ounce tubes should stop using the product and return it to their dispensing physician, the lab said.
The company said that to date, it has not received any complaints or reports of adverse events related to the recalled lot of RevitaDerm gel.