Drug product
SEMAGLUTIDE 5mg/2mL (2.5mg/mL), Rx Only 2 mL Multiple Dose Vial, Rx Only, Compounded Drug, Mfd by: ProRX Exton, PA19341, NDC 84139-225-01
D-0652-2024
Product summary
- Firm
- ProRx LLC
- Event
- Event 95190
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8,396 vials
- Official record key
drug-enforcement:D-0652-2024
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: ProRx052424, BUD 11/23/2024 ProRx060724, BUD 12/06/2024 ProRx061124, BUD 12/10/2024 ProRx061924, BUD 12/18/2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility