Sagent Pharmaceuticals: Drug Recall

Recall #D-0937-2023 · 07/11/2023

Class II: Risk

Recall Details

Recall Number: D-0937-2023
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: 760 bottles

Reason for Recall

Lack of Assurance of Sterility

Product Description

Oxacillin for Injection, USP, 10 gram per pharmacy Bulk Package bottle, For Intravenous Use, Rx only, packaged as a) NDC 25021-163-99 and b) novaplus NDC 25021-163-68, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. Made in India.

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.