Topical First-Aid Product Recalled Due to Bacterial Contamination

A popular wound care product was recalled late last month due to a bacterial contamination. Blaine Labs Company announced a voluntary recall of one lot of RevitaDerm Wound Care available to consumers because the gel was found to contain Bacillus cereus. The recall was issued on Jan. 27.

The recall covers one lot of 1.0 ounce RevitaDerm Wound Care Gel. Patients who use the contaminated gel could develop skin and soft tissue infections, which may lead to serious side effects, Blaine Labs said in a statement published at the U.S. Food and Drug Administration’s website. The infections could be treatable and less severe for most, but for immunocompromised patients and preterm neonates, exposure to Bacillus cereus can be life-threatening. It can cause wound and blood infections, as well as sepsis, pneumonia, and meningitis.

RevitaDerm Wound Care Gel is used to treat skin wounds and is packaged in 1.0-ounce bottles and 3.0-ounce tubes. The recall only covers products with the lot number BL 2844 and an expiration date reading 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,” Blaine Labs said. The gel was sent to 51 physician clinics in 17 states last year. The company has not received any reports of side effects caused by Bacillus cereus yet.

Blaine Labs is now in the process of letting its physician clients help return 1.0-ounce bottles and 3.0-ounce tubes with the lot number. Patients who already have the affected product at home should stop using it, and return to their physician. Consumers can call Blaine Labs at 800-307-8818 or email the company at info@blainelabs.com for more questions. However, they should contact their healthcare providers if they experience any problems after using the product.

Consumers can also report any adverse side-effects caused by the product to the FDA’s MedWatch Adverse Effect Reporting program. You can submit this report online by clicking here. The FDA also has a form available here that can be mailed or faxed.