Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Presence of Particulate Matter: Potential for black particulates in the drug product.
Cause type: Particulate / foreign matter
Visible foreign particles - glass, metal, fibers or other material - found in the product. Particles can enter from equipment wear, containers or the process, and are dangerous in injectables. All particulate / foreign matter recalls.
MethylPREDNISolone Acetate Injectable Suspension, USP, 400 mg per 10 mL (40 mg per mL), 1 x 10 mL Multi-Dose Vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195, Made in India. NDC: 25021-820-10
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 25021-0820 |
40 mg/mL | Injection, Suspension Intra-Articular|intralesional|intramuscular|intrasynovial|soft Tissue |
Sagent Pharmaceuticals | 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.
Failed Dissolution Specifications
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
Failed Impurities/Degradation Specifications
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product.
Lack of Assurance of Sterility
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