Sagent Pharmaceuticals Inc: Drug Recall

Recall #D-0764-2023 · 05/19/2023

Class II: Risk

Recall Details

Recall Number: D-0764-2023
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: 370,200 bottles

Reason for Recall

Lack of Assurance of Sterility

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

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.