Class I Recall for Wound Care Gel

Blaine Labs Company is voluntarily recalling a single lot of RevitaDerm Wound Care Gel (benzalkonium chloride gel containing transforming growth factor beta) .1% after a 1-ounce bottle was discovered to be contaminated with Bacillus cereus.

According to the March 30, 2022, US Food and Drug Administration (FDA) Enforcement Report, the recall has been designated Class I, suggesting use of the affected product could cause serious adverse health consequences or death.

“For the immunocompromised patients and preterm neonates, Bacillus cereus can cause life-threatening, invasive infections including wound and blood infections, sepsis, pneumonia, and meningitis,” stated the company in a January 27, 2022, announcement. “To date, Blaine Labs Company has not received any complaints or reports of adverse events related to this lot of 1.0-ounce bottles or 3.0-ounce tubes of RevitaDerm Wound Care Gel.”

The recall affects RevitaDerm Wound Care Gel .1%, packaged in 1-ounce bottles (NDC 63347-120-02) and 3-ounce tubes (NDC 63347-120-01) from lot BL 2844 (Exp. 2/19/23). The RevitaDerm Wound Care Gel product was distributed to 61 physician clinics in 17 states throughout the United States in 2021, according to the company’s announcement.

Blaine Labs Company initiated the recall January 25, 2022, and the FDA issued its Class I designation March 18, 2022.

RevitaDerm Wound Care Gel is an antimicrobial product designed to promote tissue regeneration.