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FDAFDA · Food and drugs·Recall number D-0437-2022

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

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
07-2021-12@6 12-09-2021, 07-2021-19@7 12-16-2021, 07-2021-26@5 12-23-2021, 08-2021-02@8 12-30-2021, 08-2021-09@10 01-06-2022, 08-2021-13@6 01-10-2022, 08-2021-18@4 01-15-2022, 08-2021-24@8 01-21-2022, 08-2021-30@5 01-27-2022, 09-2021-07@11 02-04-2022, 09-2021-13@5 02-10-2022 & 10-2021-04@9 03-03-2022.
Risk classification
Class II
Area (FDA)
drug
Country
United States

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