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).
LT Topical Cream
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
Cause type: cGMP deviation
Departures from current Good Manufacturing Practice found in production or during FDA inspection. A broad quality-system cause: the batch was made under conditions that fall short of FDA manufacturing standards. All cgmp deviation recalls.
What was recalled
LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose Container for Topical Use, Edge Pharma, LLC, 856 Hercules, VT, Colchester, VT 05446, NDC 05446-1647-01
Affected NDC
5446-1647-01
Compare with the code on your package — it is the most precise check available.
Drug: Lidocaine
- Recalling firm
- Edge Pharma, LLC
- NDC code
- 05446-1647-01
- Origin
- VT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0436-2022 · 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
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Class II · Moderate risk
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Class II · Moderate risk
Xylocaine (lidocaine HCl Injection, USP)
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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 Edge Pharma, LLC
All 2021 recalls
Class II · Moderate risk
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Class II · Moderate risk
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Class II · Moderate risk
Promethazine HCl Topical Ointment
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