Blaine Labs
FirmLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
- Drug recalls: 9
- 510(k) clearances: 1
Records by Year
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
Latest Records
Newest first across sources; each opens the record| Date | Record | Source |
|---|---|---|
| Apr 8, 2026 | TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 LockpClass II · CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry | Drug recalls |
| Apr 8, 2026 | Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) CrClass II · CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry | Drug recalls |
| Apr 8, 2026 | Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ (37 mL) bottle, shorter twist cap, Manufactured By: Blaine LabsClass I · Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other B | Drug recalls |
| Apr 8, 2026 | TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle, Manufactured For: Trifluent Pharma, LLC, San Antonio, Class II · CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry | Drug recalls |
| Apr 8, 2026 | Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as (a) 1.0 Fl OZ (16 mL) bottle, long pointy cap, NDC Class II · CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contamin | Drug recalls |
| Apr 8, 2026 | vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe SClass II · CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry | Drug recalls |
| Apr 8, 2026 | TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0.1%), 1.0 fl oz, (29.6 mL) bottle with long pointy cap, Manufactured for:Class II · CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contamin | Drug recalls |
| Apr 8, 2026 | TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante FClass II · CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry | Drug recalls |
| Jul 25, 2000 | BLAINE SCARCARE PATCHK001608 · MDA | 510(k) clearances |
Names and Identifiers
- Appears as
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built