Methylprednisolone Acetate Injection, Suspension
FDA Recall NDC 55150-313
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 55150-313). A significant event, classified as Class II, was initiated on Feb 20, 2024 by Eugia Us Llc. The reported reason for this action was: "Failed Dissolution Specifications"
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
Failed Dissolution Specifications
Feb 20, 2024
Mar 13, 2024
10,080 vials
Recall Profile & Regulatory Data
Event ID
94075
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Eugia US LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
OH, TN, LA, MS
Product Description
Methylprednisolone acetate Injectable Suspension, USP, 400mg per 5mL (80mg/mL, 5mL Multiple-Dose Vial, Rx only, Mfd. in India for: Eugia US LLC, E. Windsor, NJ 08520, NDC 55150-314-01
Batch or Lot Expiration Information
Lot# : 3MA23001, 3MA23002, 3MA23003, Exp 3/31/2025
Affected Packages Involved in this Recall
55150-313-25Product
55150-313-01Product
55150-314-25Product
55150-314-01Product
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.
