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

FDA recall notice · announced May 24, 2023 · Sanofi-aventis U.s

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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

Reason for recall

Lack of Assurance of Sterility: Malformed crimped collar seal

Notes

Distribution: Nationwide in the USA
Lot/code information: Lot # 3F497B, EXP 12-31-2025
Quantity: 51,325 vials
Status: Ongoing
Products in this recall event:
- 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 (D-0575-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.