Why it was recalled
Failed Dissolution Specifications
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 3MA23001, 3MA23002, 3MA23003, Exp 3/31/2025
Where it was sold
OH, TN, LA, MS
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0366-2024
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Feb 20, 2024
- FDA report date
- Mar 13, 2024
- Quantity
- 10,080 vials
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Eugia US LLC
Original FDA data
Every field from FDA enforcement report D-0366-2024, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 94075
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot #: 3MA23001, 3MA23002, 3MA23003, Exp 3/31/2025
- Postal code
- 08520-1401
- Report date
- Mar 13, 2024
- Product type
- Drugs
- Recall number
- D-0366-2024
- Classification
- Class II
- Recalling firm
- Eugia US LLC
- Product quantity
- 10,080 vials
- Reason for recall
- Failed Dissolution Specifications
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- OH, TN, LA, MS
- Recall initiation date
- Feb 20, 2024
- Initial firm notification
- Letter
- Center classification date
- Mar 4, 2024