Drug product
TIRZEPATIDE 60 mg/3mL (20/mg/mL), Rx Only, 3mL Multiple Dose Vial, Mfd by: ProRx Exton, PA, 19341, NDC 84139-210-02
D-0656-2024
Product summary
- Firm
- ProRx LLC
- Event
- Event 95190
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1,732 vials
- Official record key
drug-enforcement:D-0656-2024
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot# ProRx052224, BUD 11/21/2024 ProRx061024, BUD 12/09/2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility