Why it was recalled
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
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%).
Lot numbers, UPCs & expiration codes
Lot #s: 796CP-0006, Exp 02/2024; 796CP-0007, Exp 03/2024.
Where it was sold
Nationwide in the USA and Canada.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0270-2023
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Feb 9, 2023
- FDA report date
- Feb 22, 2023
- Quantity
- 4709 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- HTO Nevada, Inc.
Original FDA data
Every field from FDA enforcement report D-0270-2023, exactly as published.
Show all FDA fields
- City
- Lake Oswego
- State
- OR
- Status
- Terminated
- Country
- United States
- Event ID
- 91694
- Address
- 6400 Rosewood St
- Code information
- Lot #s: 796CP-0006, Exp 02/2024; 796CP-0007, Exp 03/2024.
- Postal code
- 97035-5392
- Report date
- Feb 22, 2023
- Product type
- Drugs
- Recall number
- D-0270-2023
- Classification
- Class II
- Recalling firm
- HTO Nevada, Inc.
- Product quantity
- 4709 bottles
- Termination date
- Nov 17, 2023
- Reason for recall
- cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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%).
- Distribution pattern
- Nationwide in the USA and Canada.
- Recall initiation date
- Feb 9, 2023
- Initial firm notification
- Letter
- Center classification date
- Feb 15, 2023