Drug product
Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC 25021-163-99 and b) novaplus NDC 25021-163-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.
D-0937-2023
Product summary
- Event
- Event 92678
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 760 bottles
- Official record key
drug-enforcement:D-0937-2023
Official wording
Reason: Lack of Assurance of Sterility
Code information: Lot: a) OXT202, exp 5/31/2025; OXT203, exp 5/31/2025; OXT301, exp 12/31/2025; b) OXT205, exp 6/30/2025; OXT204, exp 5/31/2025
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility