Status
Terminated
Drug Enforcement D-0270-2023
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Classification
Class II
Report Date
February 22, 2023
Termination Date
November 17, 2023
Product Information
- Product description
- 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%).
- Product quantity
- 4709 bottles
- Reason for recall
- cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide in the USA and Canada.
Location & Firm
- Recalling firm
- HTO Nevada, Inc.
- Address
-
6400 Rosewood St, N/A
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0270-2023
- Event ID
- 91694
- Recall initiation date
- February 9, 2023
- Center classification date
- February 15, 2023
- Code info
- Lot #s: 796CP-0006, Exp 02/2024; 796CP-0007, Exp 03/2024.
- More code info
- —