Blaine Labs recalls REVITADERM Wound Care Gel due to Bacillus cereus contamination. FDA analysis found microbial contamination in non-sterile product. Stop using affected lots immediately.
Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
Blaine Labs is recalling REVITADERM Wound Care Gel because FDA testing found it contaminated with Bacillus cereus bacteria. This poses a risk of infection since the product is intended for non-sterile wound care use. Affected products were sold with specific lot numbers and expiration dates.
The gel was found to contain Bacillus cereus bacteria, which can cause infections in non-sterile wound care products. Since wound care products are meant for direct contact with wounds, this contamination could lead to serious infections if used improperly.
People who own or use REVITADERM Wound Care Gel with the specific lot numbers and expiration dates listed in the recall are affected. Those with open wounds or using the product for wound care are at highest risk.
Check for the product name 'REVITADERM Wound Care Gel' in 29.6 mL bottles (NDC 633:120-02) or 88.7 mL tubes (NDC 63347-120-01). The lot number is BL 2844 with an expiration date of 2/19/2023.
Immediately stop using REVITADERM Wound Care Gel with lot number BL 2844 that expires 2/19/2023.
No, the FDA found Bacillus cereus contamination in this product, which can cause infections. Do not use it.
Stop using it immediately and contact Blaine Labs for further instructions.
Look for the product name 'REVITADERM Wound Care Gel' in 29.6 mL bottles (NDC 63347-120-02) or 88.7 mL tubes (NDC 63347-120-01) with lot number BL 2844 and expiration date 2/19/2023.
We’ve drafted a message you can send Blaine Labs to request your refund or repair — edit it as you like.
Subject: Recall D-0668-2022 — Blaine Labs Blaine Labs Hello, I own a Blaine Labs that is covered by recall D-0668-2022 from Blaine Labs. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
