Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewa
Summary
The FDA issued a Class II for Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx by Sanofi-Aventis U.S. LLC. Reason: Lack of Assurance of Sterility: Malformed crimped collar seal.
Details
Source
Drug Recall
External ID
D-0575-2023
Action Date
2023-05-24
Status
Ongoing
Category
drug
Product Description
Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgewater, NJ 08807 A Sanofi Company. NDC 0024-5926-05
Lot/Code Info: Lot # 3F497B, EXP 12-31-2025
Quantity Affected: 51,325 vials
Reason for Recall
Lack of Assurance of Sterility: Malformed crimped collar seal
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2023-04-11
Company
Bridgewater, NJ
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 99 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
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 (Sanofi-Aventis U.S. LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Sanofi-Aventis U.S. LLC have FDA actions?
This is the only FDA action we have on record for Sanofi-Aventis U.S. LLC in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0575-2023" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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