Drug 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%).
D-0270-2023
Product summary
- Firm
- HTO Nevada, Inc.
- Event
- Event 91694
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4709 bottles
- Official record key
drug-enforcement:D-0270-2023
Official wording
Reason: cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Code information: Lot #s: 796CP-0006, Exp 02/2024; 796CP-0007, Exp 03/2024.
Distribution pattern: Nationwide in the USA and Canada.
Derived failure modes
-
Manufacturing or process control
cGMP Deviation