Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container for Intranasal Use,...
FDA Recall #D-0447-2022 — Class II — December 6, 2021
Product Description
Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container for Intranasal Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1195-03, packaged in bottles.
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
114 bottles
Distribution
nationwide
Code Information
06-2021-08@5 12-05-2021, 07-2021-07@7 01-03-2022, 07-2021-27@10 01-23-2022 & 10-2021-06@12 04-04-2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated