FDA Drug recall D-0518-2019
Cefuroxime 10 mg/mL in Sodium Chloride, Intravitreal injection, 1 mL in a 2mL Vial, Ophthalmic Use Only, Office Use Only, Leiter's (800) 29…
- FDA Drug
- Class II
- terminated
- Published 2019-03-13
On 2019-03-13 the FDA classified a Class II recall of Cefuroxime 10 mg/mL in Sodium Chloride, Intravitreal injection, 1 mL in a 2mL Vial, Ophthalmic Use Only, Office Use Only, Leiter's (800) 29… by Leiter S Enterprises, citing incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0518-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-02-19 |
| Published | 2019-03-13 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Leiter S Enterprises |
| Distribution | AZ, CA, MI, NY |
Product
Cefuroxime 10 mg/mL in Sodium Chloride, Intravitreal injection, 1 mL in a 2mL Vial, Ophthalmic Use Only, Office Use Only, Leiter's (800) 292-6772- 17 Great Oaks Blvd., San Jose, CA 95119. NDC: 70360-007-35.
Reason
Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.
Identifiers
| code_info | Lot # 1811195, Exp. Date: 05/01/19 |
|---|
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-0518-2019%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.