Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumbu...
FDA Recall #D-0763-2023 — Class II — May 19, 2023
Product Description
Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-140-10
Reason for Recall
Lack of Assurance of Sterility
Recalling Firm
Sagent Pharmaceuticals Inc — Schaumburg, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2,249,980 vials
Distribution
Nationwide USA
Code Information
Lots: NFL101, NFL102, EXP: 1/31/2024; Lots: NFL103, NFL104, EXP: 5/31/2024; Lot: NFL201, EXP: 03/31/2025; Lot: NFL202, EXP: 5/31/2025;
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated