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Blaine Labs Inc FDA Recalls
9 recalls on file across drugs, 2 of them Class I and 8 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as (a) 1.0 Fl OZ (16 mL) bottle, lClass IIApr 8, 2026CGMP Deviations; product manufactured in the same facility u |
| Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ (37 mL) bottle, shorter twist cap, ManufactClass IApr 8, 2026Microbial contamination of Non-Sterile Product: samples iden |
| TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0.1%), 1.0 fl oz, (29.6 mL) bottle with long pointy caClass IIApr 8, 2026CGMP Deviations: product manufactured in the same facility u |
| TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Manufactured By: Blaine Labs, Inc., 11037 LocClass IIApr 8, 2026CGMP Deviations; the firm discontinued required stability te |
| Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (MiClass IIApr 8, 2026CGMP Deviations; the firm discontinued required stability te |
| vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle, Manufactured By: Blaine Labs, Inc., 11037 LockpoClass IIApr 8, 2026CGMP Deviations; the firm discontinued required stability te |
| TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine LabClass IIApr 8, 2026CGMP Deviations; the firm discontinued required stability te |
| TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle, Manufactured For: Trifluent PharmaClass IIApr 8, 2026CGMP Deviations; the firm discontinued required stability te |
| REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth factor-b), 0.1%, packaged in 2Class IJan 25, 2022Microbial Contamination of Non-sterile Product; FDA analysis |