Recalls / Class II
Class IID-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
- Brand name
- Methylprednisolone Acetate
- Generic name
- Methylprednisolone Acetate
- Active ingredient
- Methylprednisolone Acetate
- Route
- Intra-articular, Intralesional, Intramuscular, Soft Tissue
- NDCs
- 55150-313, 55150-314
- FDA application
- ANDA211930
- Affected lot / code info
- Lot #: 3MA23001, 3MA23002, 3MA23003, Exp 3/31/2025
Why it was recalled
Failed Dissolution Specifications
Recalling firm
- Firm
- Eugia US LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 10,080 vials
- Distribution pattern
- OH, TN, LA, MS
Timeline
- Recall initiated
- 2024-02-20
- FDA classified
- 2024-03-04
- Posted by FDA
- 2024-03-13
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0366-2024. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.