Recall archive / FDA drug enforcement
Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive procedure, distributed by: DERMAL SOURCE... — FDA record D-0271-2023
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Feb 9, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- 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.
- Classification
- Class II
- Recalling firm
- HTO Nevada, Inc.
- Quantity
- 1,571 bottles
- Agency-reported status
- Terminated
- Source record identifier
- D-0271-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot #: 795CP-0003, Exp 07/2024. |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Nationwide in the USA and Canada.
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Feb 22, 2023
- Recall initiation date
- Feb 9, 2023
- Center classification date
- Feb 15, 2023
- Termination date
- Nov 17, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.