Blaine Labs Revitaderm Wound Care Gel Recalled for Bacillus Contamination
The FDA has recalled Revitaderm Wound Care gel (Benzalkonium Chloride 0.1%) distributed nationwide due to contamination with Bacillus cereus. The affected product was distributed to 45 doctors in 17 states.
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: This is an FDA Class I recall of a non-sterile drug product contaminated with Bacillus cereus, a pathogenic bacterium. Per the severity rubric, FDA Class I recalls are never scored below 4, and the microbial contamination of a topical wound-care product represents a significant health risk.
Plain-English summary
Blaine Labs Inc. is recalling Revitaderm Wound Care gel, a topical wound-care product containing benzalkonium chloride 0.1% and transforming growth factor-beta. The product is supplied in 29.6 mL (1.0 FL OZ) bottles (NDC 63347-120-02) and 88.7 mL (3.0 FL OZ) tubes (NDC 63347-120-01).
The FDA analysis found the product to be contaminated with Bacillus cereus, a bacterium that can pose health risks when applied to non-sterile products. The affected product includes Lot/Batch #BL 2844 with an expiration date of 2/19/2023.
The contaminated product was distributed nationwide in 17 states to 45 doctors. Consumers and healthcare providers who have this product should stop using it immediately and contact their healthcare provider if they have any concerns about exposure.
The recalled product
- Product
- REVITADERM WOUND CARE (BENZALKONIUM CHLORIDE)
- Brand
- REVITADERM WOUND CARE
- 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/Batch #: BL 2844
- Expiration date 2/19/2023
Distribution
Distributed nationwide across the United States.
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