FDAFDA · Food and drugs·Recall number D-0439-2022
Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% Raspberry Marshmallow, 30 grams per jar, Multiple Dose Container For Topical Oral Use,Edge Pharma LLC, 856 Hercules Dr. Colchester, VT 05446, NDC 05446-0790-10
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
- 07-2021-20@7 01-16-2022, 08-2021-11@6 02-07-2022, 08-2021-31@11 02-01-2022, 09-2021-14@11 02-01-2022, 09-2021-21@6 02-01-2022 & 10-2021-12@4 04-10-2022.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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