CLASS I Drug recall · Reported 30 Mar 2022 · FDA Enforcement Report
Revitaderm Wound Care Gel, (Benzalkonium Chloride recalled
Blaine Labs is recalling Revitaderm Wound Care Gel, (Benzalkonium Chloride in a gel containing transforming growth, distributed nationwide in the US. The recall was initiated on 25 Jan 2022 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0668-2022
- FDA event ID
- 89481
- Recalling firm
- Blaine Labs, Santa Fe Springs, CA
- Manufacturer
- Blaine Labs Inc.
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 25 Jan 2022
- FDA classified
- 18 Mar 2022
- Reported
- 30 Mar 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Other Bacterial Contamination
- Drug class
- Creams, Ointments & Gels
Timeline
| 25 Jan 2022 | Recall initiated by company | |
| 18 Mar 2022 | Classified by FDA | +52 days |
| 30 Mar 2022 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
Product as listed by the FDA
REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth factor-b), 0.1%, packaged in 29.6 mL (1.0 FL OZ) bottles (NDC 63347-120-02) and 88.7 mL (3.0 FL OZ) tubes (NDC 63347-120-01), Blaine Labs Inc., Santa Fe Springs, CA 90670
Where it was distributed
Nationwide in 17 States to 45 doctors.
Questions about this recall
Why was it recalled?
Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
Which lots are affected?
Lot/Batch #: BL 2844, Expiration date 2/19/2023
Where was it sold?
Nationwide in 17 States to 45 doctors.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Blaine Labs
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|---|---|---|---|---|---|
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| Drug | CLASS II | vite20 Antifungal Cream, (10% Undecylenic Acid) recalled by Blaine Labs | Blaine Labs | Potency & Assay | Nationwide |
| Drug | CLASS II | Revitaderm Wound Care, First Aid Antiseptic Gel recalled by Blaine LabsRevitaderm Wound Care | Blaine Labs | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Tripenicol S Antifungal Solution (Undecylenic Acid 25%) recalledTripenicol S | Blaine Labs | Potency & Assay | Nationwide |
Other Benzalkonium Chloride recalls
All 21| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Trifluent Pharma Tridergel Wound Care Gel recalled by Blaine LabsTridergel | Blaine Labs | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Revitaderm Wound Care, First Aid Antiseptic Gel recalled by Blaine LabsRevitaderm Wound Care | Blaine Labs | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Cleansing Towelette (Benzalkonium Chloride 0.13%) recalledMed Nap Cleansing Towelette | Acme United | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%) recalledGreen Guard Antiseptic Wipes | Acme United | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Medi-First Antiseptic Wipes recalled by Acme UnitedMedi-first Antiseptic Wipes | Acme United | Manufacturing (CGMP) Deviations | Nationwide |