Admelog recalled over sterility concerns

Recall date

April 11, 2023

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Sanofi-Aventis U.S. LLC recalls Admelog, insulin lispro injection, 100 units/mL (U-100), 3mL multi-dose vial, Rx Only, Sanofi-Aventis U.S. LLC, Bridgew…

Recall number

D-0575-2023

FDA classification

Class II

Brand / firm

Sanofi-Aventis U.S. LLC

Sold / distributed

Nationwide in the USA

Why it was recalled

Lack of Assurance of Sterility: Malformed crimped collar seal

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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