Drug product
Tirzepatide 2 mL (10 mg/mL) and 20 mg/mL, 2mL Multidose SC Injection vials, Compounded Rx Product, ProRx 267-565-7008, NDC 84139-210-01
D-0651-2024
Product summary
- Firm
- ProRx LLC
- Event
- Event 95190
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 37 vials
- Official record key
drug-enforcement:D-0651-2024
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot # ProRx040924-1, BUD 10/08/2024
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility