Drug product
Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-225-08
D-0116-2026
Product summary
- Firm
- ProRx LLC
- Event
- Event 97808
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8,310 vials
- Official record key
drug-enforcement:D-0116-2026
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot Prorx051425-2, Lot Prorx051425-3 and Lot Prorx051425-4
Distribution pattern: TX and UT
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility