1. Home
  2. Labeler Index
  3. Sagent Pharmaceuticals
  4. 25021-146
  5. FDA Recall: Oxacillin

FDA Recall Oxacillin

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The last Recall Enforcement Report for Oxacillin with NDC 25021-146 was initiated on 07-11-2023 as a Class II recall due to lack of assurance of sterility The latest recall number for this product is D-0935-2023 and the recall is currently ongoing .

Recall Number Initiation Date Report Date Recall Classification Product Quantity Product Description Status
D-0935-202307-11-202308-02-2023Class II65,710 vials for 1 g and 2 g strengthOxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. NDC 25021-146-10.Ongoing
D-0936-202307-11-202308-02-2023Class II65,710 vials for 1 g and 2 g strengthOxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a) NDC 25021-162-24 and b) novaplus NDC 25021-162-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.Ongoing

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.