Product: 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 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