Class II · Moderate risk
TRIFLUENT PHARMA TRIDERGEL Wound Care Gel
CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated
Revitaderm Wound Care (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
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 cap, NDC 63347-120-01; Manufactured By: Blaine Labs, Inc. 11037 Lockport Place, Santa Fe Springs, CA 90670,
Affected NDCs
63347-0120-01
63347-0120-02
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 |
|---|---|---|---|---|
| RevitaDERM Wound Care Benzalkonium Chloride NDC 63347-0120 |
170 mg/89mL | Gel Topical |
Blaine Labs Inc. | OTC |
- Recalling firm
- Blaine Labs Inc
- NDC code
- 63347-120-02
- Origin
- CA, United States
- Initiated by
- Voluntary: Firm initiated
- Company announcement
- Apr 8, 2026 · FDA notice with lot numbers
- FDA recall number
- D-0699-2026 · 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
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Class II · Moderate risk
Dynarex
CGMP Deviations
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Class II · Moderate risk
TERPENICOL Antifungal Cream
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
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