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

FDA recall notice · announced March 13, 2024 · Eugia Us

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

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

Reason for recall

Failed Dissolution Specifications

Notes

Distribution: OH, TN, LA, MS
Lot/code information: Lot #: 3MA23001, 3MA23002, 3MA23003, Exp 3/31/2025
Quantity: 10,080 vials
Status: Ongoing
Products in this recall event:
- 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 (D-0366-2024)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.