D-0575-2023 Class II Ongoing
FDA drug recall D-0575-2023 was initiated by Sanofi-Aventis U.S. LLC on April 11, 2023 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Malformed crimped collar seal The recall status is ongoing. Affected quantity: 51,325 vials.
Recall Details
- Product Type
- Drugs
- Report Date
- May 24, 2023
- Initiation Date
- April 11, 2023
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 51,325 vials
Product Description
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
Distribution Pattern
Nationwide in the USA
Code Information
Lot # 3F497B, EXP 12-31-2025