Recalls / Class II
Class IID-0575-2023
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
- Brand name
- Admelog
- Generic name
- Insulin Lispro
- Active ingredient
- Insulin Lispro
- Route
- Intravenous, Subcutaneous
- NDCs
- 0024-5924, 0024-5925, 0024-5926
- FDA application
- BLA209196
- Affected lot / code info
- Lot # 3F497B, EXP 12-31-2025
Why it was recalled
Lack of Assurance of Sterility: Malformed crimped collar seal
Recalling firm
- Firm
- Sanofi-Aventis U.S. LLC
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 55 Corporate Dr, N/A, Bridgewater, New Jersey 08807-1265
Distribution
- Quantity
- 51,325 vials
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2023-04-11
- FDA classified
- 2023-05-15
- Posted by FDA
- 2023-05-24
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0575-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.