# FDA recall D-0518-2019

> **Leiter's Enterprises, Inc.** · Class II · drug recall initiated 2019-02-19.

## 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.

## Distribution

CA, AZ, MI, NY

## Key facts

- **Recall number:** D-0518-2019
- **Recalling firm:** Leiter's Enterprises, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-02-19
- **Report date:** 2019-03-13
- **Termination date:** 2020-02-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** San Jose, CA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0518-2019

## Citation

> AI Analytics. FDA recall D-0518-2019. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0518-2019. Source: US FDA. Licensed CC0.

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