Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Li
Summary
The FDA issued a Class II for Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGUL by Eli Lilly & Company. Reason: CGMP Deviations.
Details
Source
Drug Recall
External ID
D-0445-2024
Action Date
2024-04-24
Status
Completed
Category
drug
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
Lot/Code Info: Batch number: D608951C, exp 4/10/2025
Quantity Affected: 700 vials
Reason for Recall
CGMP Deviations
Distribution
Nationwide USA
Type: Voluntary: Firm initiated
Recall Initiated: 2024-03-12
Company
Indianapolis, IN
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 26 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Eli Lilly & Company has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Eli Lilly & Company) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Eli Lilly & Company have FDA actions?
Eli Lilly & Company has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0445-2024" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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