Sagent Pharmaceuticals Inc: Drug Recall

Recall #D-0435-2023 · 02/28/2023

Class II: Risk

Recall Details

Recall Number: D-0435-2023
Classification: Class II
Product Type: Drug
Recalling Firm: Sagent Pharmaceuticals Inc
Status: Completed
Date Initiated: 02/28/2023
Location: Schaumburg, IL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 28,875 vials

Reason for Recall

Labeling: Not elsewhere classified

Product Description

Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx Only, For Intravenous or Subcutaneous Use, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195; Made in India, NDC carton: 25021-404-01

Distribution Pattern

USA Nationwide

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 05/19/2023

Lack of Assurance of Sterility
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.