Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Labeling: Label Mixup: methylPREDNISolone, Tablet, 4 mg may have potentially been mislabeled as one of the following drugs: LEVOTHYROXINE SODIUM, Tablet, 112 mcg, NDC 00378181101, Pedigree: AD52778_37, EXP: 5/20/2014; NABUMETONE, Tablet, 500 mg, NDC 00185014501, Pedigree: AD46426_4, EXP: 5/15/2014; CHOLECALCIFEROL, Tablet, 2000 units, NDC 00904615760, Pedigree: AD54586_10, EXP: 5/21/2014.
methylPREDNISolone, Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781502201.
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason Labeling: Not Elsewhere Classified. Incorrect orientation of the blister foil applied to the blister cavities, which results in incorrect dosing…
Reason Presence of Particulate Matter: Potential for black particulates in the drug product.
Reason Failed Dissolution Specifications
Reason Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary…
Reason Lack of sterility assurance
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