One lot of RevitaDerm wound care gel is being recalled due to bacterial contamination, according to the FDA.
The recall was issued after one bottle of the prescription-only product was found to contain Bacillus cereus, which can cause infections like sepsis, pneumonia, and meningitis.
Consumers who bought any recalled RevitaDerm from their doctors should stop using it immediately and return it, the company warns.
Double-check your medicine cabinet: One lot of RevitaDerm, a wound care gel, is being recalled due to bacterial contamination, per a notice posted by the Food and Drug Administration (FDA).
Blaine Labs triggered the voluntary recall after testing revealed that one bottle of RevitaDerm contained Bacillus cereus, a bacteria that could lead to “life-threatening, invasive infections,” per the FDA. No adverse events related to this recall have been reported yet.
RevitaDerm, a skin antimicrobial, is packaged as 1-ounce bottles and 3-ounce tubes. Only products from lot BL 2844 (which has an expiration date of February 19, 2023) are included in the recall. Though RevitaDerm products are available in many pharmacies and online, the specific wound-care item being recalled is only available from doctors; it is not sold at stores. The recalled lot was distributed to 61 physician clinics in 17 states.
Consumers who have the recalled RevitaDerm product should stop using it immediately and return it, the company warns.
Bacillus cereus could develop skin and soft tissue infections when the contaminated product is applied to wounds, the FDA says, although these are easier to treat in people without immunocompromising conditions. Those that are immunocompromised and preterm babies face the most risk from the bacteria: “Life-threatening, invasive infections, including wound and blood infections, sepsis, pneumonia, and meningitis” are possible, the FDA warns.
The bacteria are commonly found in soil, plants, and food, according to the National Center for Biotechnology Information. It’s most commonly ingested, causing symptoms like nausea, vomiting, and diarrhea.
Blaine Labs says it is notifying physicians of the recall, meaning your doctor might be able to tell you if your specific container of RevitaDerm is affected.
Consumers with questions about the recall can contact Blaine Labs at 800-307-8818 or email@example.com. If you experience any adverse effects related to the RevitaDerm recall, you can submit a report to the FDA here.
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