CLASS II Drug recall · Reported 13 Mar 2019 · FDA Enforcement Report
Cefuroxime 10 mg/mL in Sodium Chloride recalled by Leiter's Enterprises
Leiter's Enterprises is recalling Cefuroxime 10 mg/mL in Sodium Chloride, Intravitreal injection in a Vial, Ophthalmic Use, distributed in Arizona, California, Michigan, New York. The recall was initiated on 19 Feb 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0518-2019
- FDA event ID
- 82229
- Recalling firm
- Leiter's Enterprises, San Jose, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Feb 2019
- FDA classified
- 6 Mar 2019
- Reported
- 13 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Telephone
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 19 Feb 2019 | Recall initiated by company | |
| 6 Mar 2019 | Classified by FDA | +15 days |
| 13 Mar 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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.
Where it was distributed
CA, AZ, MI, NY
Questions about this recall
Why was it recalled?
Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.
Which lots are affected?
Lot # 1811195, Exp. Date: 05/01/19
Where was it sold?
CA, AZ, MI, NY
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Cefuroxime recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Cefuroxime 4mg / (10 mg/mL) syringe recalled by Pine Pharmaceuticals | Pine Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Cefuroxime, Sterile Ophthalmic Solution for Injection recalled | Edge Pharma | Sterility | Nationwide |
| Drug | CLASS II | Cefuroxime 10mg/mL INJ 0.5 mg, SDV recalled | Pacific Compounding Pharmacy & Consultations | Particulate Matter | CA |
| Drug | CLASS III | Cefuroxime, Ophthalmic Solution for Injection recalled | JCB Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS II | Cefuroxime Sodium 10 mg/mL in 0.9% Sodium Chloride recalled | Leiter's Compounding | Sterility | Nationwide |