Recall: D-0366-2024

Class II - Potentially Harmful

Class IIClassification

2024-02-20Initiated

OngoingStatus

Eugia US LLCFirm

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

Reason

Failed Dissolution Specifications

Distribution

OH, TN, LA, MS

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.