MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL...
FDA Recall #D-0499-2024 — Class II — April 25, 2024
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
Reason for Recall
Presence of Particulate Matter: Potential for black particulates in the drug product.
Recalling Firm
Sagent Pharmaceuticals — Schaumburg, IL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
14,360 vials
Distribution
Nationwide in the USA
Code Information
Lots 5100186, 5100187, 5100188, 5100189, Exp 01/31/2025
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated