Blaine Labs Inc
FDA Regulatory Profile
Blaine Labs Inc appears in FDA public data with 9 recalls — including 2 Class I (most serious) —, 1 510(k) clearance, 8 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0699-2026, Class II) was initiated on April 8, 2026. Its most recent 510(k) clearance was granted on July 25, 2000.
Summary
- Total Recalls
- 9 (2 Class I)
- 510(k) Clearances
- 1
- Inspections
- 8
- Compliance Actions
- 1
Recent Recalls
| Number | Class | Product | Date |
|---|
| D-0699-2026 | Class II | Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as (a) 1.0 Fl | April 8, 2026 |
| D-0694-2026 | Class II | TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle, Manufactured F | April 8, 2026 |
| D-0692-2026 | Class I | Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ (37 mL) bottle, shorter | April 8, 2026 |
| D-0696-2026 | Class II | vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle, Manufactured By: Blaine Labs | April 8, 2026 |
| D-0693-2026 | Class II | TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0.1%), 1.0 fl oz, (29.6 mL) bottle | April 8, 2026 |
| D-0697-2026 | Class II | TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufac | April 8, 2026 |
| D-0695-2026 | Class II | TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Manufactured By: Blaine L | April 8, 2026 |
| D-0698-2026 | Class II | Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal F | April 8, 2026 |
| D-0668-2022 | Class I | REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth factor-b), | January 25, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K001608 | BLAINE SCARCARE PATCH | July 25, 2000 |