New & Improved Blue Gel Anesthetic — Class II drug recall D-0270-2023
Terminated recall by HTO Nevada, Inc., reported 2023-02-22, distributed nationwide. cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
| Recall number | D-0270-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | HTO Nevada, Inc., Lake Oswego, OR, United States |
| Recall initiated | 2023-02-09 |
| Classified | 2023-02-15 |
| Reported by FDA | 2023-02-22 |
| Terminated | 2023-11-17 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Quantity | 4,709 bottles |
| Reason classes | cgmp |
| NDC | 80069-0008-01 |
| Lot numbers | 796CP-0006, 796CP-0007 |
| Expiration dates | 2024-02, 2024-03 |
Product
New & Improved Blue Gel Anesthetic, to reduce pain and swelling during pain sensitive procedures, 1 oz bottle, distributed by Dermal Source, Portland, OR, www.dermalsource.com 1-888-568-3223. NDC Code: 80069-008-01. Drug Facts- For use by licensed professionals only, Active Ingredients -Lidocaine HCL (5%), Tetracaine HCL (1%) and epinephrine (0.1%).
Reason for recall
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
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-0270-2023. 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.