Drug 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
D-0575-2023
Product summary
- Event
- Event 92074
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 51,325 vials
- Official record key
drug-enforcement:D-0575-2023
Official wording
Reason: Lack of Assurance of Sterility: Malformed crimped collar seal
Code information: Lot # 3F497B, EXP 12-31-2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility