PlainRecalls
FDA Drug Moderate Class II Completed

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

Reported: April 24, 2024 Initiated: March 12, 2024 #D-0445-2024

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

Details

Recalling Firm
Eli Lilly & Company
Units Affected
700 vials
Distribution
Nationwide USA
Location
Indianapolis, IN

Frequently Asked Questions

What product 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. Recalled by Eli Lilly & Company. Units affected: 700 vials.
Why was this product recalled?
CGMP Deviations
Which agency issued this recall?
This recall was issued by the FDA Drug on April 24, 2024. Severity: Moderate. Recall number: D-0445-2024.