Sanofi-Aventis U.S. LLC: Drug Recall
Recall #D-0575-2023 · 04/11/2023
Class II: Risk
Recall Details
- Recall Number
- D-0575-2023
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Sanofi-Aventis U.S. LLC
- Status
- Ongoing
- Date Initiated
- 04/11/2023
- Location
- Bridgewater, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 51,325 vials
Reason for Recall
Lack of Assurance of Sterility: Malformed crimped collar seal
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
Distribution Pattern
Nationwide in the USA
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.