FDA Drug recall D-0400-2022
Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge…
- FDA Drug
- Class II
- terminated
- Published 2022-02-02
On 2022-02-02 the FDA classified a Class II recall of Edetate Disodium (EDTA), Sterile Ophthalmic Solution (PF) 1.5%, 10 mL per dropper, Single Dose Droptainer for Topical Ophthalmic Use, Edge… by Edge Pharma, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0400-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2021-12-06 |
| Published | 2022-02-02 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Edge Pharma |
| Distribution | US |
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
Lack of Assurance of Sterility.
Identifiers
| code_info | 10-2021-20@1 02/10/2022 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0400-2022%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.