FDAFDA · Food and drugs·Recall number D-0270-2023
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%).
Published February 22, 2023 · Recall initiated: February 9, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- HTO Nevada, Inc.
- Distributor
- Nationwide in the USA and Canada.
- Lot
- Lot #s: 796CP-0006, Exp 02/2024; 796CP-0007, Exp 03/2024.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
Sell products like this?
Recalert watches your whole catalog for recalls like this one, automatically.