Drug product
SEMAGLUTIDE 10mg/4mL (2.5mg/mL), 4 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-04
D-0653-2024
Product summary
- Firm
- ProRx LLC
- Event
- Event 95190
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,960 vials
- Official record key
drug-enforcement:D-0653-2024
Official wording
Reason: Lack of Assurance of Sterility
Code information: ProRx061424, BUD 12/13/2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility