Drug product
Piperacillin and Tazobactam for Injection, USP, 4.5 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-080-02
D-0631-2023
Product summary
- Event
- Event 92341
- Status
- Terminated
- Classification
- Class II
- Quantity
- 393,930 vials
- Official record key
drug-enforcement:D-0631-2023
Official wording
Reason: Lack of Assurance of Sterility
Code information: All lots within expiry.
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility