New & Improved Blue Gel Anesthetic recall: CGMP Deviations
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%).
Why was New & Improved Blue Gel Anesthetic recalled?
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #s: 796CP-0006, Exp 02/2024; 796CP-0007, Exp 03/2024.
- 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%).
- Recalling firm
- HTO Nevada, Inc.
- Quantity
- 4709 bottles
- Distribution
- Nationwide in the USA and Canada.
- Recall date
- February 22, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)