Skip to main content

Leiter's Enterprises, Inc.

No ongoing recalls currently shown

Based on the official records currently available to Public Health Trace, no recalls naming Leiter's Enterprises, Inc. are currently shown as ongoing. The 1 record below is a historical recall record.

Public Health Trace has 1 recall naming Leiter's Enterprises, Inc. as the recalling firm, republished from official FDA and USDA sources.

Recall history - 1 terminated record

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20191
Download CSV

FDA Recall TerminatedTerminated: February 26, 2020Historical recordClass II

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.

by Leiter's Enterprises, Inc.

Reason
Incorrect Product Formulation; compounded sterile drug reconstituted using sterile water instead of sterile 0.9% Sodium Chloride.
Published
March 13, 2019
Distribution
Multiple states

View recall →

Showing 1–1 of 1 results

Some FDA recall records on this page come from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.

This page lists recalls that name Leiter's Enterprises, Inc. as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.