PlainRecalls
FDA Drug Moderate Class II Ongoing

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

Reported: March 13, 2024 Initiated: February 20, 2024 #D-0366-2024

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

Reason for Recall

Failed Dissolution Specifications

Details

Recalling Firm
Eugia US LLC
Units Affected
10,080 vials
Distribution
OH, TN, LA, MS
Location
East Windsor, NJ

Frequently Asked Questions

What product was recalled?
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. Recalled by Eugia US LLC. Units affected: 10,080 vials.
Why was this product recalled?
Failed Dissolution Specifications
Which agency issued this recall?
This recall was issued by the FDA Drug on March 13, 2024. Severity: Moderate. Recall number: D-0366-2024.