Revitaderm Wound Care Gel recalled for microbial contamination
Revitaderm Wound Care Gel has been recalled due to microbial contamination with Lysinibacillus fusiformis and other Bacillus species. The product was distributed nationwide and consumers should stop using it.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The FDA has classified this as a Class I recall, which requires a severity score of at least 4 per the rubric. The hazard involves microbial contamination of a non-sterile topical product, which poses risk of infection when applied to wounds.
Plain-English summary
Blaine Labs Inc is recalling Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, in 1.0 FL OZ (37 mL) bottles due to microbial contamination. Testing identified the presence of Lysinibacillus fusiformis and other Bacillus species in samples of the product.
The affected product is Lot #BL3608 with expiration date 07/01/28, NDC 63347-120-02, manufactured by Blaine Labs Inc, 11037 Lockport Place, Santa Fe Springs, California 90670. Approximately 1,171 bottles were distributed nationwide in the USA.
Consumers who have purchased this product should stop using it immediately. Anyone with concerns about their health should contact a healthcare provider.
The recalled product
- Product
- Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ (37 mL) bottle, shorter twist cap, Manufactured By: Blaine Labs, Inc. 11037 Lockport Place Santa Fe Springs, CA 90670, NDC 63347-120-02.
- Manufacturer
- Blaine Labs Inc
- Category
- Drug — Topical Wound Care
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot#: BL3608
- Exp. 07/01/28.
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 8 recalled by Blaine Labs Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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