Blaine Labs Recalls RevitaDerm Wound Care Gel

blainelabscompany jan28 lt

California-based Blaine Labs Co. is recalling one lot of RevitaDerm Wound Care to the consumer level citing the potential contamination with Bacillus cereus, the U.S. Food and Drug Administration said.

The product is used as a skin wound antimicrobial. It is packaged in a 1.0 ounce bottle and a 3.0 ounce tube with each labeled as "RevitaDerm Wound Care Gel" with a Drug Facts label on the back.

The affected RevitaDerm Wound Care Gel lot is BL 2844 with an expiration date of 02/19/2023. The product was distributed to 61 physician clinics in 17 states in the United States in 2021.

The recall was initiated after 1.0 ounce RevitaDerm Wound Care Gel has been found to be contaminated with Bacillus cereus.

According to FDA, Bacillus cereus is an aerobic spore-forming bacterium that is commonly found in soil, on vegetables, and in many raw and processed foods. B. cereus food poisoning may occur when foods are prepared and held without adequate refrigeration for several hours before serving.

Patients who apply the contaminated product to a wound could develop a skin and soft tissue infection which could lead to serious complications.

For non-immunocompromised patients these infections are expected to be less severe and responsive to treatment. However, for the immunocompromised patients and preterm neonates, Bacillus cereus can cause life-threatening, invasive infections including wound and blood infections, sepsis, pneumonia, and meningitis.

Blaine Labs has not received any complaints or reports of adverse events related to the recalled product to date.

Patients who have the recalled product are asked to stop using the product and return unused product to the dispensing physician.

In similar recalls, Smithfield Packaged Meats Corp., doing business as Margherita Meats, Inc., in December last year called back around 10,990 pounds of ready-to-eat or RTE pepperoni products citing possible Bacillus Cereus contamination.

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