Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human...

FDA Recall #D-0445-2024 — Class II — March 12, 2024

Recall #D-0445-2024 Date: March 12, 2024 Classification: Class II Status: Completed

Product Description

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

Reason for Recall

CGMP Deviations

Recalling Firm

Eli Lilly & Company — Indianapolis, IN

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

700 vials

Distribution

Nationwide USA

Code Information

Batch number: D608951C, exp 4/10/2025

Status

Completed

Voluntary / Mandated

Voluntary: Firm initiated