Class II · Moderate risk
Lidocaine Ointment USP
Failed Content Uniformity Specifications. Out of Specification for Assay during analysis at the 24- month long term stability station, at (25¿C,60%RH).
New & Improved Blue Gel Anesthetic
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What 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%).
Affected NDC
80069-0008-01
Compare with the code on your package — it is the most precise check available.
Drug: Lidocaine
- Recalling firm
- HTO Nevada, Inc.
- Origin
- OR, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0270-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Lidocaine recalls
See all
Class II · Moderate risk
Xylocaine (lidocaine HCl Injection, USP)
Presence of Particulate Matter: Hair was found in products
Class II · Moderate risk
Xylocaine (lidocaine HCl Injection, USP)
Presence of Particulate Matter: Hair was found in products
Class II · Moderate risk
Lidocaine HCl Injection
Presence of Particulate Matter: Hair was found in products
Class III · Low risk
Lidolog Kit
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Other recalls by HTO Nevada, Inc.
All 2023 recalls
Class II · Moderate risk
Maximum
Stability Data Does Not Support Expiry Date.
Class II · Moderate risk
Maximum
Stability Data Does Not Support Expiry Date.
Class II · Moderate risk
Five-Star
Stability Data Does Not Support Expiry Date.
Class II · Moderate risk
Maximum Zone2 Topical Analgesic
cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.
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