FDA Recall Cefepime Hydrochloride
View Recall Number, Date, Reasons, Quantity
FDA Recall Enforcement Reports
The last Recall Enforcement Report for Cefepime Hydrochloride with NDC 70594-089 was initiated on 05-15-2023 as a Class II recall due to lack of assurance of sterility The latest recall number for this product is D-0609-2023 and the recall is currently terminated as of 04-05-2024 .
| Recall Number | Initiation Date | Report Date | Recall Classification | Product Quantity | Product Description | Status |
|---|---|---|---|---|---|---|
| D-0609-2023 | 05-15-2023 | 05-24-2023 | Class II | 550,160 vials | Cefepime for Injection, USP 1 gram per vial, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-089-02 | Terminated |
| D-0610-2023 | 05-15-2023 | 05-24-2023 | Class II | 964,420 vials | Cefepime for Injection, USP 2 grams per vial, Rx only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089, NDC 70594-090-02 | Terminated |
What is the Enforcement Report?
All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.