March 2024 FDA Recall Drug by Eli Lilly & Company
D-0445-2024 - CGMP Deviations
This Class II drug recall was voluntarily initiated by Eli Lilly & Company on March 12, 2024 for the product Drug. The FDA reported the reason for recall as cgmp deviations. The product was distributed Nationwide and the recall is currently completed.
Recall Number: D-0445-2024
CGMP Deviations
03-12-2024
04-24-2024
700 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Completed
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Eli Lilly & Company
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
E-Mail
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide USA
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Batch# Batch number: D608951C, exp 4/10/2025
