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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.
FDA RecallTerminatedTerminated: 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.
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.
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