FDAFDA · Food and drugs·Recall number D-0441-2022
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
Published February 2, 2022 · Recall initiated: December 6, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations
What to do
Voluntary: Firm initiated · Press Release
Recall details
- Manufacturer
- Edge Pharma, LLC
- Distributor
- nationwide
- Lot
- 06-2021-29@15 12-26-2021, 07-2021-12@7 01-08-2022, 08-2021-03@7 01-30-2022, 08-2021-25@5 02-01-2022, 09-2021-10@4 02-01-2022, 09-2021-22@6 03-01-2022 & 10-2021-06@11 04-04-2022
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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