Edge Pharma, LLC: Drug Recall

Recall #D-0442-2022 · 12/06/2021

Class II: Risk

Recall Details

Recall Number: D-0442-2022
Classification: Class II
Product Type: Drug
Recalling Firm: Edge Pharma, LLC
Status: Terminated
Date Initiated: 12/06/2021
Location: Colchester, VT, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 175 jars

Reason for Recall

CGMP Deviations

Product Description

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

Distribution Pattern

nationwide

Other Recalls by Edge Pharma, LLC

Class II: Risk 12/06/2021

Lack of Assurance of Sterility.
Class II: Risk 12/06/2021

Lack of Assurance of Sterility
Class II: Risk 12/06/2021

Lack of Assurance of Sterility
Class II: Risk 12/06/2021

CGMP Deviations
Class II: Risk 12/06/2021

Lack of Assurance of Sterility

View all recalls by Edge Pharma, LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.