Drug product
Oxacillin 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.
D-0936-2023
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-0936-2023
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot #: a) OXL202, exp 6/30/2025; OXL204, exp 6/30/2025; OXL301, exp 12/31/2025; OXL205, exp 11/30/2025; b) OXL201, exp 5/31/2025; OXL203, exp 6/30/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility