LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose Container for Topical...
FDA Recall #D-0436-2022 — Class II — December 6, 2021
Product Description
LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose Container for Topical Use, Edge Pharma, LLC, 856 Hercules, VT, Colchester, VT 05446, NDC 05446-1647-01
Reason for Recall
CGMP Deviations
Recalling Firm
Edge Pharma, LLC — Colchester, VT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
74 jars
Distribution
nationwide
Code Information
08-2021-23@9 02-19-2022, 09-2021-07@13 03-06-2022 & 10-2021-22@5 04-20-2022.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated