Recalls / Class II
Class IID-0445-2024
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
- Brand name
- Humalog
- Generic name
- Insulin Lispro
- Active ingredient
- Insulin Lispro
- Route
- Intravenous, Subcutaneous
- NDCs
- 0002-7516, 0002-7510, 0002-7533, 0002-8799, 0002-7714, 0002-8213, 0002-0800, 0002-7712, 0002-8208
- FDA application
- BLA020563
- Affected lot / code info
- Batch number: D608951C, exp 4/10/2025
Why it was recalled
CGMP Deviations
Recalling firm
- Firm
- Eli Lilly & Company
- Manufacturer
- Eli Lilly and Company
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 893 S Delaware St, Indianapolis, Indiana 46225-1782
Distribution
- Quantity
- 700 vials
- Distribution pattern
- Nationwide USA
Timeline
- Recall initiated
- 2024-03-12
- FDA classified
- 2024-04-17
- Posted by FDA
- 2024-04-24
- Status
- Completed
Source: openFDA Drug Enforcement endpoint. Recall record D-0445-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.