Fungal Fusion antifungal kit recalled for discontinued stability testing
Blaine Labs Inc is recalling Fungal Fusion ERADICATION Solution kits nationwide because the manufacturer discontinued required stability testing for products still on the market within their expiration dates.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall involving a CGMP deviation (discontinued stability testing) without reported illnesses or injuries. This is a manufacturing compliance issue representing a potential quality risk rather than an acute hazard.
Plain-English summary
Blaine Labs Inc is recalling the Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit, which contains a Miconazole Nitrate cream, an Undecylenic Acid solution, and an antimicrobial spray. The recall affects Lot BL3572 with expiration 04/16/2028, totaling 1,500 bottles distributed nationwide in the USA.
The manufacturer discontinued required stability testing for these products while they remained on the market within their expiration dates. This deviation from current Good Manufacturing Practice (CGMP) requirements means the safety and effectiveness of the products cannot be assured over their shelf life.
Consumers should stop using the recalled product. Anyone who has used this kit and has questions or concerns should contact their healthcare provider.
The recalled product
- Product
- Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) Cream, 1x2oz bottle Fungal Fusion Antifungal Solution (25% Undecylenic Acid) and 1x1oz bottle of Fungal Fusion Eradication Antimicrobial Show
- Manufacturer
- Blaine Labs Inc
- Category
- Drug — Topical Antifungal
- Hazard
- stability-testing-failure
- cgmp-deviation
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 BL3572
- Exp 04/16/2028
Distribution
Distributed nationwide across the United States.
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