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.
What this means for you
Illness, injury, or structural failure has been reported. 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
- Hazard
- microbial-contamination
- lysinibacillus-fusiformis
- bacillus-species
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.
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