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Leiter's Enterprises, Inc.

Recalls

Recalls by year

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

Recalls by year
YearRecalls
20191
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FDA Recall Terminated Historical 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

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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.