Methylprednisolone Acetate Injection, Suspension
FDA Recall NDC 25021-821
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Methylprednisolone Acetate (NDC 25021-821). A significant event, classified as Class II, was initiated on Apr 25, 2024 by Sagent Pharmaceuticals. The reported reason for this action was: "Presence of Particulate Matter: Potential for black particulates in the drug product."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Presence of Particulate Matter: Potential for black particulates in the drug product.
Apr 25, 2024
May 22, 2024
14,360 vials
Recall Profile & Regulatory Data
Event ID
94486
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Sagent Pharmaceuticals
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
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
Batch or Lot Expiration Information
Lot# Lots 5100186, 5100187, 5100188, 5100189, Exp 01/31/2025
Affected Packages Involved in this Recall
25021-820-05Product
25021-820-10Product
25021-821-05Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
