FDA recall D-0400-2022

Edge Pharma, LLC · Class II · drug

Product

Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT, 05446, NDC 05446-1427-10

Reason for recall

Lack of Assurance of Sterility.

Distribution

nationwide

Key facts

Status: Terminated
Initiation date: 2021-12-06
Report date: 2022-02-02
Termination date: 2023-06-07
Voluntary/Mandated: Voluntary: Firm initiated
Location: Colchester, VT, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0400-2022