FDAClass IIJanuary 22, 2014

Pantoprazole Sodium DR Tablet recall: Labeling Error

PANTOPRAZOLE SODIUM DR Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62175018046

Why was Pantoprazole Sodium DR Tablet recalled?

Labeling:Label Mixup; PANTOPRAZOLE SODIUM DR, Tablet, 20 mg may be potentially mislabeled as DRONEDARONE HCL, Tablet, 400 mg, NDC 00024414260, Pedigree: AD52778_52, EXP: 5/20/2014.

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?

PANTOPRAZOLE SODIUM DR Tablet, 20 mg has the following code Pedigree: AD52778_64, EXP: 5/20/2014.

Product
PANTOPRAZOLE SODIUM DR Tablet, 20 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 62175018046
Recalling firm
Aidapak Services, LLC
Quantity
90 Tablets
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Recall date
January 22, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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