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%).