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| The United States: Blaine Labs, Inc issues voluntary nationwide recall of Wound Care Gel products due to microbial contamination (English only) |
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The US Food and Drug Administration (FDA) announces that Blaine Labs, Inc. is voluntarily recalling 3 lot numbers of Wound Care Gel products, 1 oz. & 3 oz. (0.1% Benzalkonium Chloride) to the consumer level due to microbial contamination. This voluntary recall has been initiated as a precautionary measure due to the detection of microbial presence. The tested samples identified the presence of Lysinibacillus fusiformis.
The affected products are:
- Revitaderm® Wound Care Antiseptic Gel (lot number: BL3608, 1 oz. twist cap bottle; BL3435, 1 oz. pointy cap bottle; BL3435, 3 oz. tube; BL3525, 1 oz. pointy cap bottle; BL3525, 3 oz. tube)
- Tridergel™ Wound Care (lot number: BL3435, 1 oz. pointy cap bottle)
Lysinibacillus fusiformis is an environmental, spore-forming bacterium. While it is generally considered to have low pathogenicity in healthy individuals, it can survive in adverse conditions and may act as an opportunistic organism. Patients with open wounds, compromised skin barriers, or weakened immune systems (e.g., elderly, diabetic, or immunocompromised individuals) may be at increased risk for infection, skin irritation, and / or delayed wound healing. In immunocompromised individuals, including those with poorly controlled diabetes, elderly individuals with immune senescence, and young children with an immature immune system, these infections may become severe and lead to life-threatening complications such as endocarditis or central system infection.
The product is used as a topical antiseptic for first aid to help prevent the risk of infection in minor cuts, scrapes, and burns. Revitaderm® Wound Care Antiseptic Gel 1 oz. & 3 oz. and Tridergel™ Wound Care 1 oz. was distributed nationwide in the U.S to healthcare providers (doctor’s offices), they were not distributed for retail or internet sales. To date, Blaine Labs has not received any reports of adverse events related to this recall.
Please refer to the following website in FDA for details:
http://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/blaine-labs-inc-issues-voluntary-nationwide-recall-wound-care-gel-products-due-microbial
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/Thursday, Apr 9, 2026
Issued at HKT 15:00
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