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%).
Reported: February 22, 2023 Initiated: February 9, 2023 #D-0270-2023
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%).
Reason for Recall
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Details
- Recalling Firm
- HTO Nevada, Inc.
- Units Affected
- 4709 bottles
- Distribution
- Nationwide in the USA and Canada.
- Location
- Lake Oswego, OR
Frequently Asked Questions
What product was recalled? ▼
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%).. Recalled by HTO Nevada, Inc.. Units affected: 4709 bottles.
Why was this product recalled? ▼
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on February 22, 2023. Severity: Moderate. Recall number: D-0270-2023.
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