Drug 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%).
D-0271-2023
Product summary
- Firm
- HTO Nevada, Inc.
- Event
- Event 91694
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,571 bottles
- Official record key
drug-enforcement:D-0271-2023
Official wording
Reason: cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Code information: Lot #: 795CP-0003, Exp 07/2024.
Distribution pattern: Nationwide in the USA and Canada.
Derived failure modes
-
Manufacturing or process control
cGMP Deviation