Key Takeaway

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 by Sanofi-Aventis U.S. LLC was recalled on April 11, 2023. The hazard: Lack of Assurance of Sterility: Malformed crimped collar seal

FDA Drug Class II Ongoing

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

Recalled: April 11, 2023 ~51,325 vials units affected D-0575-2023

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

Hazard / Reason

Lack of Assurance of Sterility: Malformed crimped collar seal

Class II: Product that may cause temporary or medically reversible health consequences.

Class II indicates the product may cause temporary or medically reversible health effects. The probability of serious harm is considered remote.

Products Affected

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

Drugs

Company Information

Sanofi-Aventis U.S. LLC

Bridgewater, NJ, United States

View all 22 recalls by Sanofi-Aventis U.S. LLC →

Distribution

Nationwide in the USA

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Frequently Asked Questions

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