The Recall Desk

Manufacturer

Leiter's Enterprises, Inc.

1 recall in our database name Leiter's Enterprises, Inc. as the manufacturing or recalling firm.

What the numbers show

Total
1
Critical
0
Severe
1
Most recent
2019-03-13

Of the 1 recalls from Leiter's Enterprises, Inc. we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 1 (100%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–1 of 1

  • SevereFDA (Drugs)·D-0518-2019·2019-03-13

    Leiter's Recalls Cefuroxime Intravitreal Injection Due to Incorrect Formulation

    Leiter's Enterprises is recalling 569 vials of Cefuroxime 10 mg/mL intravitreal injection because the drug was compounded with sterile water instead of sterile 0.9% Sodium Chloride.

    Product
    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.
    Category
    Drug
    Distribution
    4 states