FDA recall D-0437-2022

Edge Pharma, LLC · Class II · drug

Product

LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%, 3 mL per syringe, Single Dose Syringe for Topical Use, Edge Pharma, LLC, 856 Hercules Dr. Colchester, VT, NDC 05446-0607-01

Reason for recall

CGMP Deviations

Distribution

nationwide

Key facts

Status: Terminated
Initiation date: 2021-12-06
Report date: 2022-02-02
Termination date: 2023-06-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Colchester, VT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0437-2022