FDAClass IIJanuary 22, 2014

tiZANidine HCL Tablet recall: Labeling Error

tiZANidine HCL Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57664050289

Why was tiZANidine HCL Tablet recalled?

Labeling:Label Mixup; tiZANidine HCL Tablet, 2 mg may be potentially mislabeled as NICOTINE POLACRILEX, Lozenge, 2 mg, NDC 37205098769, Pedigree: AD70700_4, EXP: 5/29/2014; NIFEdipine ER, Tablet, 60 mg, NDC 00591319401, Pedigree: W003729, 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?

tiZANidine HCL, Tablet, 2 mg has the following codes Pedigree: AD70700_10, EXP: 5/29/2014; Pedigree: W003750, EXP: 6/26/2014.

Product
tiZANidine HCL Tablet, 2 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 57664050289
Recalling firm
Aidapak Services, LLC
Quantity
299 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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