Eli Lilly & Company: Drug Recall

Recall #D-0445-2024 · 03/12/2024

Class II: Risk

Recall Details

Recall Number: D-0445-2024
Classification: Class II
Product Type: Drug
Recalling Firm: Eli Lilly & Company
Status: Completed
Date Initiated: 03/12/2024
Location: Indianapolis, IN, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 700 vials

Reason for Recall

CGMP Deviations

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

Distribution Pattern

Nationwide USA

Other Recalls by Eli Lilly & Company

Class I: Dangerous 09/24/2021

SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.
Class II: Risk 08/19/2021

Labeling: Label error on declared strength - autoinjector devices labeled as 0.75 mg / 0.5 mL actually contain 1.5 mg / 0.5 mL of product.
Class II: Risk 06/29/2021

cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.

View all recalls by Eli Lilly & Company →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.