FDA Drug recall D-0668-2022
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)…
- FDA Drug
- Class I
- terminated
- Published 2022-03-30
On 2022-03-30 the FDA classified a Class I recall of 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)… by Blaine Labs, citing microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0668-2022 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2022-01-25 |
| Published | 2022-03-30 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Blaine Labs |
| Distribution | US |
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
Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
Identifiers
| ndc | 63347-120-01 |
|---|---|
| ndc | 63347-120-02 |
| code_info | Lot/Batch #: BL 2844, Expiration date 2/19/2023 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0668-2022%22
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