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%).

Recall Number: D-0271-2023

Firm: HTO Nevada, Inc.

Classification: Class II

Status: Terminated

Report Date: 20230222

Initiation Date: 20230209

Termination Date: 20231117

Reason for Recall

cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.

Product Description

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%).