FDA recall D-0366-2024

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 for recall

Failed Dissolution Specifications

Distribution

OH, TN, LA, MS

Key facts

Status

Ongoing

Initiation date

2024-02-20

Report date

2024-03-13

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Windsor, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0366-2024