LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%, 3 mL per syringe, ...
FDA Recall #D-0437-2022 — Class II — December 6, 2021
Product Description
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
Recalling Firm
Edge Pharma, LLC — Colchester, VT
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
26917 syringes
Distribution
nationwide
Code Information
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.
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated