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%).
Class I - DangerousWhat Should You Do?
- Check if you have this product: Lot #s: 796CP-0006, Exp 02/2024; 796CP-0007, Exp 03/2024.
- Do not eat it: Even if it looks and smells fine, do not consume this product.
- Throw it away or return it: You can return the product to the store for a full refund.
- Seek medical attention if needed: If you've consumed this product and feel unwell, contact your doctor immediately.
- Report problems: Report any issues to the FDA's Safety Reporting Portal.
⚠️ Emergency: If you experience severe symptoms after consuming this product, call 911 or Poison Control at 1-800-222-1222.
Recall Details
- Company:
- HTO Nevada, Inc.
- Reason for Recall:
- cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
- Classification:
- Class I - Dangerous
Dangerous or defective products that predictably could cause serious health problems or death.
- Status:
- terminated
Product Information
Full 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 Codes/Lot Numbers:
Lot #s: 796CP-0006, Exp 02/2024; 796CP-0007, Exp 03/2024.
Official Source
Always verify recall information with the official FDA source:
View on FDA.govFDA Recall Number: D-0270-2023
Related Recalls
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.