Oxacillin for Injection, USP, 2 grams per vial, For IV or IM Use, Rx only, labeled as a) NDC 2502...
FDA Recall #D-0936-2023 — Class II — July 11, 2023
Product Description
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.
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
65,710 vials for 1 g and 2 g strength
Distribution
Nationwide in the USA
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
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated