Class II · Moderate risk Ongoing
Xylocaine
Reason Presence of Particulate Matter: Hair was found in products
Profound-PE Dental Gel
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations
What was recalled
Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenylephrin HCl, 10% / 10% / 4% / 2% Raspberry-Marshmallow, Multiple Dose Container for Topical Oral Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT NDC 05446-1018-10
- Recalling firm
- Edge Pharma, LLC
- NDC code
- 05446-1018-10
- Origin
- VT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0441-2022
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Lidocaine recalls
See all
Class II · Moderate risk Ongoing
Xylocaine
Reason Presence of Particulate Matter: Hair was found in products
Class II · Moderate risk Ongoing
Lidocaine HCl Injection
Reason Presence of Particulate Matter: Hair was found in products
Class III · Low risk Ongoing
Lidolog Kit
Reason Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Class II · Moderate risk Ongoing
Lidocaine HCl Injection USP
Reason Lack of Assurance of Sterility
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