Drug Enforcement D-0445-2024

CGMP Deviations

Status

Completed

Classification

Class II

Report Date

April 24, 2024

Termination Date

—

Product Information

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
Product quantity
700 vials
Reason for recall
CGMP Deviations
Recall initiation reason
—
Initial firm notification
E-Mail
Distribution pattern
Nationwide USA

Location & Firm

Recalling firm
Eli Lilly & Company
Address
893 S Delaware St

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0445-2024
Event ID
94214
Recall initiation date
March 12, 2024
Center classification date
April 17, 2024
Code info
Batch number: D608951C, exp 4/10/2025
More code info
—