Drug recall
Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion…
FDA recall event 98731 · Class I, Class II · Blaine Labs Inc
Key facts
| Event ID | 98731 |
|---|---|
| Recall numbers | D-0692-2026, D-0693-2026, D-0694-2026, D-0695-2026, D-0696-2026, D-0697-2026, D-0698-2026, D-0699-2026 |
| Recalling firm | Blaine Labs Inc |
| Product type | Drugs |
| Products | Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial Kit. Contains, 1x2 oz bottle Fungal Fusion Antifungal (Miconazole Nitrate) Cream, 1x2oz bottle Fungal Fusion Antifungal Solution (25%…, 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 63347-120-02; (b) 3.0 Fl OZ (85 g) tube, with short twist…, 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…, TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, NDC 63347-601-01., TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670. NDC 63347-600-01 and 3 more |
| Classification | Class I, Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary: Firm Initiated |
| Reason for recall | CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated, CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated, CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry, Microbial contamination of… |
| Initiation date | Apr 8, 2026 |
| Report date | Jul 8, 2026 |
| City | Santa Fe Springs |
| State | CA |
| Country | United States |
| FEI number | 3001744192 |
At a glance
- 1–9 Products in this recall
- 10–99 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: