Dexamethasone sodium phosphate 0.4%, 120 mL per bottle, Multiple Dose Container For Topical Use, ...
FDA Recall #D-0433-2022 — Class II — December 6, 2021
Product Description
Dexamethasone sodium phosphate 0.4%, 120 mL per bottle, Multiple Dose Container For Topical Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-0622-01
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
56 cartons
Distribution
nationwide
Code Information
06-2021-23@6 12-20-2021, 09-2021-15@4 03-14-2022 & 10-2021-04@10 04-02-2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated