Class II · Moderate risk
Revitaderm Wound Care
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
TRIFLUENT PHARMA TRIDERGEL Wound Care Gel (Benzalkonium Chloride)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0.1%), 1.0 fl oz, (29.6 mL) bottle with long pointy cap, Manufactured for: Trifluent Pharma, LLC. San Antonio, TX 78213. NDC 73352-520-01.
Affected NDC
73352-0520-01
Compare with the code on your package — it is the most precise check available.
Drug: Benzalkonium
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Tridergel Benzalkonium Chloride NDC 73352-0520 |
.001 g/mL | Gel Topical |
Trifluent Pharma LLC | OTC |
- Recalling firm
- Blaine Labs Inc
- NDC code
- 73352-520-01
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0693-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Benzalkonium recalls
See all
Class I · High risk
Revitaderm Wound Care Gel
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
Class III · Low risk
Lidocaine Wound Gel
Failed PH Specifications
Class II · Moderate risk
Children's Healthcare of Atlanta
CGMP Deviations
Class II · Moderate risk
Dynarex
CGMP Deviations
Other recalls by Blaine Labs Inc
All 2026 recalls
Class II · Moderate risk
Revitaderm Wound Care
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Class II · Moderate risk
Fungal Fusion ERADICATION Solution
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Class II · Moderate risk
TERPENICOL Antifungal Solution
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Class II · Moderate risk
vite20 Antifungal Cream
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
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