Drug 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
D-0366-2024
Product summary
- Firm
- Eugia US LLC
- Event
- Event 94075
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10,080 vials
- Official record key
drug-enforcement:D-0366-2024
Official wording
Reason: Failed Dissolution Specifications
Code information: Lot #: 3MA23001, 3MA23002, 3MA23003, Exp 3/31/2025
Distribution pattern: OH, TN, LA, MS
Derived failure modes
-
Potency or specification failure
Failed Dissolution Specifications