Sterile Diluent recalled over manufacturing violations

Recall date

March 12, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Eli Lilly & Company recalls Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin L…

Recall number

D-0445-2024

FDA classification

Class II

Brand / firm

Eli Lilly & Company

Sold / distributed

Nationwide USA

Why it was recalled

CGMP Deviations

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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