FDAClass IIJanuary 22, 2014

Isosorbide Dinitrate ER Tablet recall: Labeling Error

ISOSORBIDE DINITRATE ER Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57664060088

Why was Isosorbide Dinitrate ER Tablet recalled?

Labeling:Label Mixup; ISOSORBIDE DINITRATE ER Tablet, 40 mg may be potentially mislabeled as CILOSTAZOL, Tablet, 50 mg, NDC 60505252101, Pedigree: AD21811_7, EXP: 5/1/2014.

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?

ISOSORBIDE DINITRATE ER, Tablet, 40 mg has the following code Pedigree: AD23082_4, EXP: 5/3/2014.

Product
ISOSORBIDE DINITRATE ER Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57664060088
Recalling firm
Aidapak Services, LLC
Quantity
100 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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