REVITADERM WOUND CARE GEL — Class I drug recall D-0668-2022
Terminated recall by Blaine Labs Inc, reported 2022-03-30, distributed nationwide. Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillu
| Recall number | D-0668-2022 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Blaine Labs Inc, Santa Fe Springs, CA, United States |
| Recall initiated | 2022-01-25 |
| Classified | 2022-03-18 |
| Reported by FDA | 2022-03-30 |
| Terminated | 2022-08-01 |
| Distributed | Nationwide (US) |
| Reason classes | microbial contamination, sterility |
| Pathogens | bacillus cereus |
| NDC | 63347-0120, 63347-0120-01, 63347-0120-02 |
| Lot numbers | 2844 |
| Expiration dates | 2023-02-19 |
Product
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
Reason for recall
Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0668-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.