Blaine Labs is voluntarily recalling 1 lot of RevitaDerm Wound Care Gel to the consumer level due to contamination with Bacillus cereus.
RevitaDerm Wound Care Gel is used as a skin wound antimicrobial. The product is supplied in a 1.0 ounce bottle and a 3.0 ounce tube. The recalled lot of RevitaDerm Wound Care Gel, Lot # BL2844; Expiration Date 02/19/2023, was distributed to 61 physician clinics in 17 states in the United States in 2021.
According to the Company, application of the affected product to a wound could result in serious complications, particularly for immunocompromised individuals and preterm neonates. Bacillus cereus, an aerobic spore-forming bacterium, can cause life-threatening, invasive infections including wound and blood infections, sepsis, pneumonia, and meningitis.
To date, the Company has not received any complaints or reports of adverse events related to this recall.
Adverse reactions or quality problems should be reported to the Food and Drug Administration’s MedWatch program.
For more information regarding this recall contact Blaine Labs at (800) 307-8818 or by email at [email protected].
Blaine Labs issues voluntary nationwide recall of RevitaDerm Wound Care Gel due to bacterial contamination. News release. Blaine Labs Inc. Accessed January 27, 2022. https://www.prnewswire.com/news-releases/blaine-labs-issues-voluntary-nationwide-recall-of-revitaderm-wound-care-gel-due-to-bacterial-contamination-301469441.html