Cefuroxime 10 mg/mL in Sodium Chloride — Class II drug recall D-0518-2019
Terminated recall by Leiter's Enterprises, Inc., reported 2019-03-13, distributed in AZ, CA, MI, NY. Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.
| Recall number | D-0518-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Leiter's Enterprises, Inc., San Jose, CA, United States |
| Recall initiated | 2019-02-19 |
| Classified | 2019-03-06 |
| Reported by FDA | 2019-03-13 |
| Terminated | 2020-02-26 |
| Distributed | AZ, CA, MI, NY |
| Quantity | 569 vials |
| Reason classes | sterility |
| NDC | 70360-0007-35 |
| Lot numbers | 1811195 |
| Expiration dates | 2019-05-01 |
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 for recall
Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0518-2019. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.