Drug product
Oxacillin 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.
D-0935-2023
Product summary
- Event
- Event 92678
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 65,710 vials for 1 g and 2 g strength
- Official record key
drug-enforcement:D-0935-2023
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: OXG301, Exp 12/31/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility