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 for recall: cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Recall initiated: 20230209
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated