FDAClass IIJanuary 22, 2014

Cinacalcet HCL Tablet recall: Labeling Error

CINACALCET HCL Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55513007430

Why was Cinacalcet HCL Tablet recalled?

Labeling:Label Mixup; CINACALCET HCL Tablet, 60 mg may be potentially mislabeled as RANOLAZINE ER, Tablet, 500 mg, NDC 61958100301, Pedigree: W003741, EXP: 6/26/2014.

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?

CINACALCET HCL, Tablet, 60 mg has the following code Pedigree: W003742, EXP: 6/26/2014.

Product
CINACALCET HCL Tablet, 60 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 55513007430
Recalling firm
Aidapak Services, LLC
Quantity
60 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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