Methylprednisolone acetate Injectable Suspension recall
FDA recall D-0366-2024 · initiated Feb 20, 2024
Eugia US LLC recalled Methylprednisolone acetate Injectable Suspension in Feb 2024 — an FDA Class II recall (D-0366-2024) because Failed Dissolution Specifications.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Dissolution Specifications
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 10,080 vials
Details
- 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
- Recalling company
- Eugia Pharma
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- OH, TN, LA, MS
- Initiated
- Feb 20, 2024
- FDA report date
- Mar 13, 2024
Frequently asked
- Was Methylprednisolone acetate Injectable Suspension recalled?
- Eugia US LLC recalled Methylprednisolone acetate Injectable Suspension in Feb 2024 — an FDA Class II recall (D-0366-2024) because Failed Dissolution Specifications. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Methylprednisolone acetate Injectable Suspension recalled?
- Per the FDA enforcement record, the reason for recall D-0366-2024 was: Failed Dissolution Specifications
- Is a recalled Methylprednisolone acetate Injectable Suspension dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Methylprednisolone acetate Injectable Suspension are affected?
- Distributed: OH, TN, LA, MS. The recall covers these lots — Lot #: 3MA23001, 3MA23002, 3MA23003, Exp 3/31/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0366-2024.