FDA MedWatch - RevitaDerm Wound Care Gel by Blaine Labs:

U.S. Food and Drug Administration sent this bulletin at 01/28/2022 11:16 AM EST

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MedWatch - The FDA Safety Information and Adverse Event Reporting Program

TOPIC: RevitaDerm Wound Care Gel by Blaine Labs: Recall - Due to Bacterial Contamination

AUDIENCE: Patient, Consumer, Health Professional, Pharmacy, Dermatology

ISSUE: Blaine Labs is recalling one lot of RevitaDerm Wound Care because a bottle of the 1.0 ounce RevitaDerm Wound Care Gel has been found to be contaminated with Bacillus cereus.

Risk Statement: 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.

To date, Blaine Labs has not received any complaints or reports of adverse events.

For more information about this recall, click on the red button "Read Recall" below.

BACKGROUND: RevitaDerm Wound Care Gel is used as a skin wound antimicrobial.

RECOMMENDATIONS:

Patients who have the RevitaDerm Wound Care Gel 1.0 ounce bottle or 3.0 ounce tubes, which are being recalled, should stop using the product and return unused product to the dispensing physician.

Consumers with questions regarding this recall can contact Blaine Labs.

Consumers should contact their physicians or healthcare provider if they have experienced any problems that may be related to using this drug product.

Health professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:

Complete and submit the report online.
Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on form, or submit by fax to 1-800-FDA-0178.

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