FDA Drug recall D-0271-2023
Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive procedure, distributed by: DERMAL SOURCE, Portland, OR, www.de…
- FDA Drug
- Class II
- terminated
- Published 2023-02-22
On 2023-02-22 the FDA classified a Class II recall of Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive procedure, distributed by: DERMAL SOURCE, Portland, OR, www.de… by Hto Nevada, citing cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0271-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-02-09 |
| Published | 2023-02-22 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Hto Nevada |
| Distribution | US |
Product
Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive procedure, distributed by: DERMAL SOURCE, Portland, OR, www.dermalsource.com, 1-866-568-3223, NDC code: 80069-012-01, Drug Facts- For use by licensed professionals only' Active Ingredients- Lidocaine HCL (5%), Epinephrine (0.01%).
Reason
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Identifiers
| code_info | Lot #: 795CP-0003, Exp 07/2024. |
|---|
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-0271-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.