Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumbu...

FDA Recall #D-0762-2023 — Class II — May 19, 2023

Recall #D-0762-2023 Date: May 19, 2023 Classification: Class II Status: Ongoing

Product Description

Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-139-10

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

Lot: NFG101, EXP: 1/31/2024; Lot: NFG102, EXP: 9/30/2024; Lot: NFG201, 5/31/2025

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated