FDA Drug · D-0575-2023

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

Class II · Ongoing

Lack of Assurance of Sterility: Malformed crimped collar seal

Affected lots / codes — check yours against thisLot # 3F497B, EXP 12-31-2025

Recalling firm: Sanofi-Aventis U.S. LLC, Bridgewater, NJ
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 51,325 vials
Distribution: Nationwide in the USA
Recall initiated: April 11, 2023
Classified: May 15, 2023
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0575-2023%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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