Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Cause type: Cross-contamination
Traces of another drug - most often penicillin - got into the product from shared equipment or facilities. Even trace penicillin can trigger a severe allergic reaction in someone who was never meant to receive it. All cross-contamination recalls.
MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-917-11
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 NDC 68382-0917 |
8 mg/1 | Tablet Oral |
Zydus Pharmaceuticals USA Inc. | 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. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
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.
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: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity.
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
CGMP Deviations; presence of N-Nitroso-Desmethyl-Erythromycin above the recommended acceptable intake limit
Failed Tablet/Capsule specifications: Red dots inside capsule and melted capsule caused by oxidized Icosapent ethyl, the active ingredient.
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