FDA Drug recall D-0010-2020
C-EDETATE DISODIUM 1.5% OPHTH SOLUTION, 10 ML droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 070…
- FDA Drug
- Class II
- terminated
- Published 2019-10-09
On 2019-10-09 the FDA classified a Class II recall of C-EDETATE DISODIUM 1.5% OPHTH SOLUTION, 10 ML droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 070… by Colonia Care Pharmacy, citing lack of Assurance of Sterility: product sterility cannot be guaranteed.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0010-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-07-24 |
| Published | 2019-10-09 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Colonia Care Pharmacy |
| Distribution | NJ |
Product
C-EDETATE DISODIUM 1.5% OPHTH SOLUTION, 10 ML droptainer bottle, Rx only, Colonia Care Pharmacy, 515 Inman Ave., Suite A, Colonia, N.J. 07067
Reason
Lack of Assurance of Sterility: product sterility cannot be guaranteed.
Identifiers
| code_info | Lot #: 072219B, BUD 08/05/19 |
|---|
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-0010-2020%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.