Stop using now Drug recall · FDA · Published February 19, 2019

Leiter's Recalls Cefuroxime Intravitreal Injections Due to Wrong Formulation

Leiter's Enterprises recalls 569 vials of Cefuroxime intravitreal injection because it was reconstituted with sterile water instead of sodium chloride.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0518-2019Drug Leiter's Enterprises ›

Stop using this now

Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.

Take action

Contact the company

Recalling firmLeiter's Enterprises, Inc.17 Great Oaks Blvd · San Jose, CA 95119-1359

✎ GovInfoNow plain-language explainer

Leiter's Enterprises, Inc. is recalling a specific lot of Cefuroxime 10 mg/mL in Sodium Chloride intended for intravitreal injection. The product was incorrectly compounded using sterile water rather than the required sterile 0.9% Sodium Chloride. This recall affects 569 vials distributed to medical offices in California, Arizona, Michigan, and New York. Read more at govinfonow.com/recall/39187-leiter-s-recalls-cefuroxime-intravitreal-injections-due-to-wrong-formulation.

Source Summary by GovInfoNow · govinfonow.com/recall/39187-leiter-s-recalls-cefuroxime-intravitreal-injections-due-to-wrong-formulation · Updated October 11, 2026 · FDA enforcement record: FDA #D-0518-2019

Cite this page

“Leiter's Recalls Cefuroxime Intravitreal Injections Due to Wrong Formulation.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/39187-leiter-s-recalls-cefuroxime-intravitreal-injections-due-to-wrong-formulation. Based on FDA recall #D-0518-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0518-2019%22&limit=1).

The FDA announced on Feb. 19, 2019, that Leiter's Enterprises, Inc. voluntarily recalled Cefuroxime Intravitreal Injection due to incorrect product formulation. The hazard involves the drug being reconstituted with sterile water instead of sterile 0.9% Sodium Chloride.

How to tell if you have it

Brand: Leiter's Enterprises
Product: Cefuroxime Intravitreal Injection
NDC: 70360-007-35
Lot #: 1811195
Expiration Date: 05/01/19
Distribution: CA, AZ, MI, NY

The hazard

The compounded sterile drug was reconstituted using sterile water instead of sterile 0.9% Sodium Chloride, resulting in an incorrect product formulation.

Context

GovInfoNow's records show other recent recalls of similar products include Fagron Recalls Tropicamide Eye Drops Due to Incorrect Formulation (2025-11-20), Imprimis NJOF recalls intraocular injection with glass particles (2025-12-18), and Fresenius Kabi 0.9% Sodium Chloride Injection Recall: Lack of Sterility Assurance (2026-03-11).

How to tell if you have this one

Check for Cefuroxime 10 mg/mL in Sodium Chloride, Intravitreal injection, 1 mL in a 2mL Vial. Look for NDC: 70360-007-35 and Lot # 1811195 with an expiration date of 05/01/19.

Brand
Leiter's Enterprises
Category
Drug

Based on the official FDA remedy

What to do — step by step

Stop using the product
Do not administer any vials matching the recalled lot number to patients.
Contact the manufacturer
Call Leiter's Enterprises, Inc. at (800) 292-6772 for further instructions on returning or disposing of the product.

Where it went and when

Where it was distributed

Distributed in 4 states.

FDA distribution: “CA, AZ, MI, NY” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Arizona, California, Michigan, New York.

Recall timeline

FDA terminated this recall 12 months after the firm started it.

Feb 19, 2019Firm started the recall
Mar 6, 2019FDA classified it Class II
Mar 13, 2019Published in FDA’s Enforcement Report
Feb 26, 2020FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/39187-leiter-s-recalls-cefuroxime-intravitreal-injections-due-to-wrong-formulation">Leiter's Recalls Cefuroxime Intravitreal Injections Due to Wrong Formulation (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0518-2019 (February 19, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0518-2019 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 11, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.