PlainRecalls
FDA Drug Moderate Class II Terminated

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

Reported: February 2, 2022 Initiated: December 6, 2021 #D-0433-2022

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

Details

Recalling Firm
Edge Pharma, LLC
Units Affected
56 cartons
Distribution
nationwide
Location
Colchester, VT

Frequently Asked Questions

What product was recalled?
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. Recalled by Edge Pharma, LLC. Units affected: 56 cartons.
Why was this product recalled?
CGMP Deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on February 2, 2022. Severity: Moderate. Recall number: D-0433-2022.