FDA-Drug2023-05-24Class II

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

Sanofi-Aventis U.S. LLC
Hazard

Lack of Assurance of Sterility: Malformed crimped collar seal

Sold states
Nationwide in the USA
Affected count
51,325 vials
Manufactured in
55 Corporate Dr, N/A, Bridgewater, NJ, United States
Products
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

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0575-2023

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