Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx o...
FDA Recall #D-0937-2023 — Class II — July 11, 2023
Product Description
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.
Reason for Recall
Lack of Assurance of Sterility
Recalling Firm
Sagent Pharmaceuticals — Schaumburg, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
760 bottles
Distribution
Nationwide in the USA
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated