Class IICompleted

Sterile Diluent recall

FDA recall D-0445-2024 · initiated Mar 12, 2024

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

CGMP Deviations

Details

Product: Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Lispro Injection u-100, 10 mL, Use ONLY with Insulins listed on carton, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285. NDC: 0002-0800-01
Recalling company: Eli Lilly Co
Classification: Class II
Status: Completed
Type: Voluntary: Firm initiated
Distribution: Nationwide USA
Initiated: Mar 12, 2024
FDA report date: Apr 24, 2024

This recall is linked to a product we cover: Humalog →

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0445-2024 ↗

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