Sagent Pharmaceuticals: Drug Recall

Recall #D-0935-2023 · 07/11/2023

Class II: Risk

Recall Details

Recall Number: D-0935-2023
Classification: Class II
Product Type: Drug
Recalling Firm: Sagent Pharmaceuticals
Status: Ongoing
Date Initiated: 07/11/2023
Location: Schaumburg, IL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 65,710 vials for 1 g and 2 g strength

Reason for Recall

Lack of Assurance of Sterility

Product Description

Oxacillin for Injection, USP, 1 gram per vial, For IV or IM Use, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India. NDC 25021-146-10.

Distribution Pattern

Nationwide in the USA

Other Recalls by Sagent Pharmaceuticals

Class I: Dangerous 05/28/2024

Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Class I: Dangerous 05/28/2024

Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Class II: Risk 04/25/2024

Presence of Particulate Matter: Potential for black particulates in the drug product.
Class II: Risk 07/11/2023

Lack of Assurance of Sterility
Class II: Risk 07/11/2023

Lack of Assurance of Sterility

View all recalls by Sagent Pharmaceuticals →

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.