Sagent Pharmaceuticals Inc: Drug Recall

Recall #D-0762-2023 · 05/19/2023

Class II: Risk

Recall Details

Recall Number: D-0762-2023
Classification: Class II
Product Type: Drug
Recalling Firm: Sagent Pharmaceuticals Inc
Status: Ongoing
Date Initiated: 05/19/2023
Location: Schaumburg, IL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2,249,980 vials

Reason for Recall

Lack of Assurance of Sterility

Product Description

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

Distribution Pattern

Nationwide USA

Other Recalls by Sagent Pharmaceuticals Inc

Class II: Risk 05/19/2023

Lack of Assurance of Sterility
Class II: Risk 05/19/2023

Lack of Assurance of Sterility
Class II: Risk 02/28/2023

Labeling: Not elsewhere classified
Class II: Risk 03/11/2021

Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may result in a non-sterile product.

View all recalls by Sagent Pharmaceuticals Inc →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.