FDAClass IIJanuary 29, 2014

Isosorbide Dinitrate recall: Labeling Error

ISOSORBIDE DINITRATE, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781155601.

Why was Isosorbide Dinitrate recalled?

Labeling: Label Mixup: ISOSORBIDE DINITRATE, Tablet, 10 mg may have potentially been mislabeled as one of the following drugs: SODIUM CHLORIDE, Tablet, 1 mg, NDC 00223176001, Pedigree: AD22845_10, EXP: 5/2/2014; CALCITRIOL, Capsule, 0.5 mcg, NDC 63304024001, Pedigree: AD32757_10, EXP: 5/14/2014.

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, Tablet, 10 mg has the following codes: Pedigree: AD25264_1, EXP: 5/3/2014; Pedigree: AD32757_34, EXP: 5/14/2014.

Product
ISOSORBIDE DINITRATE, Tablet, 10 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00781155601.
Recalling firm
Aidapak Services, LLC
Quantity
384 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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