FDAClass IIJanuary 29, 2014

Tolterodine Tartrate ER recall: Labeling Error

TOLTERODINE TARTRATE ER, Capsule, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00009519001.

Why was Tolterodine Tartrate ER recalled?

Labeling: Label Mixup: TOLTERODINE TARTRATE ER, Capsule, 2 mg may be potentially mislabeled as one of the following drugs: RANOLAZINE ER , Tablet, 500 mg, NDC 61958100301, Pedigree: AD62995_7, EXP: 5/29/2014; FERROUS SULFATE, Tablet, 325 mg (65 mg Elem Fe), NDC 00904759160, Pedigree: W002717, EXP: 6/6/2014.

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?

TOLTERODINE TARTRATE ER, Capsule, 2 mg has the following codes: Pedigree: AD65478_1, EXP: 5/29/2014; Pedigree: W002724, EXP: 6/6/2014.

Product
TOLTERODINE TARTRATE ER, Capsule, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00009519001.
Recalling firm
Aidapak Services, LLC
Quantity
60 Capsules
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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