Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmac...

FDA Recall #D-0764-2023 — Class II — May 19, 2023

Recall #D-0764-2023 Date: May 19, 2023 Classification: Class II Status: Ongoing

Product Description

Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-141-99

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

370,200 bottles

Distribution

Nationwide USA

Code Information

Lot: NFT101, EXP: 5/31/2024; Lots: NFT201, NFT202, EXP: 2/28/2025; Lots: NFT203, NFT204, EXP: 5/31/2025

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated