Drug product
Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-04
D-0115-2026
Product summary
- Firm
- ProRx LLC
- Event
- Event 97808
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8,400 vials
- Official record key
drug-enforcement:D-0115-2026
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot, Best Use Date (BUD): Lot PRORX050925-1, BUD November 4, 2025; Lot ProRx051425-5, BUD November 10, 2025; Lot ProRx051425-6, BUD November 10, 2025
Distribution pattern: TX and UT
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility