Recall Enforment Report D-0271-2023

Multi event Drug Recall Enforcement Report Class II voluntary initiated by HTO Nevada, Inc., originally initiated on 02-09-2023 for the 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%). The product was recalled due to cgmp deviation: raw material recalled by repackager, due to discoloration of the epinephrine api.. The product was distributed nationwide and the recall is currently terminated.

Recall Enforcement Reports

Recall Number Recall Initiation Date Report Date Recall Classification Quantity Product Description Recall Reason Status
D-0271-202302-09-202302-22-2023Class II1,571 bottlesMaximum 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%).cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.Terminated
D-0270-202302-09-202302-22-2023Class II4709 bottlesNew & Improved Blue Gel Anesthetic, to reduce pain and swelling during pain sensitive procedures, 1 oz bottle, distributed by Dermal Source, Portland, OR, www.dermalsource.com 1-888-568-3223. NDC Code: 80069-008-01. Drug Facts- For use by licensed professionals only, Active Ingredients -Lidocaine HCL (5%), Tetracaine HCL (1%) and epinephrine (0.1%).cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.Terminated

Recalled Products

NDC Proprietary Name Non-Proprietary Name Dosage Form Route Name Company Name Product Type
80069-012Zone 2 Lidocaine Hcl, EpinephrineGelTopicalDermal Source, Inc.Human Otc Drug