MedicineWatch US
Class II Recall

Edge Pharma, LLC

Product
Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenylephrine, 10% / 10% / 4% / 2%, Spear-Peppermint, Multiple Dose Container for Topical Oral Use, 30 grams per jar, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-0408-10
Reason
CGMP Deviations
Classification
Class II
Status
Terminated
Lot
07-2021-13@7 01-09-2022 08/24/21 - 10/06/21 07-2021-27@8 01-23-2022 10/06/21 - 11/02/21 08-2021-10@5 02-01-2022 10/28/21 - 12/01/21
Date
Disclaimer: This tool indexes published US FDA drug-enforcement recall records from all countries, limited to the latest five years. A company or product not appearing here is not proof that it is compliant, approved, safe, or free of FDA action.