Sagent Pharmaceuticals: Drug Recall

Recall #D-0499-2024 · 04/25/2024

Class II: Risk

Recall Details

Recall Number: D-0499-2024
Classification: Class II
Product Type: Drug
Recalling Firm: Sagent Pharmaceuticals
Status: Ongoing
Date Initiated: 04/25/2024
Location: Schaumburg, IL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 14,360 vials

Reason for Recall

Presence of Particulate Matter: Potential for black particulates in the drug product.

Product Description

MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10

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 07/11/2023

Lack of Assurance of Sterility
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.