Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Failed Dissolution Specifications
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
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
Compare with the code on your package — it is the most precise check available.
Drug: Methylprednisolone
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Methylprednisolone Acetate NDC 55150-0314 |
80 mg/mL | Injection, Suspension Intra-Articular|intralesional|intramuscular|soft Tissue |
Eugia US LLC | Rx |
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing information when following the directions on the foil.
Presence of Particulate Matter: Potential for black particulates in the drug product.
Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number 70121-1573-1; Correct NDC Number 70121-1574-1.
Lack of sterility assurance
cGMP deviations: Temperature abuse
Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan
Failed Stability Specifications: Out of specification results for the Color Absorbance test during 12 Month sample analysis.
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
Out-of-Specification test results were obtained in at long term conditions during 3 month's stability study for related substances.
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