Drug product
Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Lispro Injection u-100, 10 mL, Use ONLY with Insulins listed on carton, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285. NDC: 0002-0800-01
D-0445-2024
Product summary
- Event
- Event 94214
- Status
- Completed
- Classification
- Class II
- Quantity
- 700 vials
- Official record key
drug-enforcement:D-0445-2024
Official wording
Reason: CGMP Deviations
Code information: Batch number: D608951C, exp 4/10/2025
Distribution pattern: Nationwide USA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations