Drug product
Semaglutide, 2 mL (2.5mg/mL), Compounded RX Product, Multidose SC inj, glass vial, ProRx, 267-565-7008, NDC 84139-225-01
D-0650-2024
Product summary
- Firm
- ProRx LLC
- Event
- Event 95190
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,490 vials
- Official record key
drug-enforcement:D-0650-2024
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: ProRx031924, BUD 09/18/2024 ProRx032624, BUD 09/25/2024 ProRx041324, BUD 10/12/2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility