Drug product
Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutaneous Use, Rx Only, Mfd by: ProRx, 619 Jeffers Cir, Exton, PA 19341. NDC: 84139-209-03
D-0120-2026
Product summary
- Firm
- ProRx LLC
- Event
- Event 97808
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 2,761 vials
- Official record key
drug-enforcement:D-0120-2026
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot PRORX08062025-3
Distribution pattern: TX and UT
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility