FDAClass IIJanuary 29, 2014

methylPREDNISolone recall: Labeling Error

methylPREDNISolone, Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781502201.

Why was methylPREDNISolone recalled?

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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

methylPREDNISolone, Tablet, 4 mg has the following codes: Pedigree: AD52778_43, EXP: 5/20/2014; Pedigree: AD46426_10, EXP: 5/15/2014; Pedigree: AD54587_7, EXP: 5/21/2014.

Product
methylPREDNISolone, Tablet, 4 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781502201.
Recalling firm
Aidapak Services, LLC
Quantity
300 Tablets
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Recall date
January 29, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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