Safety Report: RevitaDerm Wound Care Gel - recalled due to Bacillus cereus contamination, USA

United States

Blaine Labs Company is voluntarily recalling one lot of RevitaDerm Wound Care to the consumer level 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 Company has not received any complaints or reports of adverse events related to this lot of 1.0 ounce bottle or 3.0 ounce tube of RevitaDerm Wound Care Gel.

The product is used as a skin wound antimicrobial and 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 can be identified by its name on the front of either the 1.0 ounce bottle or the 3.0 ounce tube, and the 1.0 ounce volume has the witch-hat dispensing cap. The RevitaDerm Wound Care Gel Product was distributed to 61 physician clinics in 17 states in the United States in the year 2021.

Blaine Labs is notifying its physician clients by email, regular mail and by phone, and is arranging for the return of undispensed 1.0 ounce bottles and 3.0 ounce tubes from lot BL 2844. 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 should contact their physicians or healthcare provider if they have experienced any problems that may be related to using this drug product.

Company name: Blaine Labs Company
Brand name: RevitaDerm
Product recalled: Wound Care Gel
Reason of the recall: May be contaminated with Bacillus cereus
FDA Recall date: January 27, 2022
   
Check the full recall details on www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/blaine-labs-issues-voluntary-nationwide-recall-revitaderm-wound-care-gel-due-bacterial-contamination

Source: FDA