New & 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%).
Reason
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Classification
Class II
Status
Terminated
Lot
Lot #s: 796CP-0006, Exp 02/2024; 796CP-0007, Exp 03/2024.
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.
HTO Nevada, Inc. — Class II Recall | MedicineWatch US