February 2024 FDA Recall Methylprednisolone Acetate by Eugia Us Llc
D-0366-2024 - Failed Dissolution Specifications
This Class II drug recall was voluntarily initiated by Eugia Us Llc on February 20, 2024 for the product Methylprednisolone Acetate. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed in OH, TN, LA, MS and the recall is currently ongoing.
Recall Number: D-0366-2024
Failed Dissolution Specifications
02-20-2024
03-13-2024
10,080 vials
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Eugia US LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
OH, TN, LA, MS
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
