FDAClass IIJanuary 29, 2014

Cetirizine HCL recall: Labeling Error

CETIRIZINE HCL, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378363501.

Why was Cetirizine HCL recalled?

Labeling: Label Mixup: CETIRIZINE HCL, Tablet, 5 mg may have potentially been mislabeled as the following drug: LITHIUM CARBONATE ER, Tablet, 300 mg, NDC 00054002125, Pedigree: AD39564_1, EXP: 5/13/2014.

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?

CETIRIZINE HCL, Tablet, 5 mg has the following codes: Pedigree: AD32757_13, EXP: 5/13/2014.

Product
CETIRIZINE HCL, Tablet, 5 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00378363501.
Recalling firm
Aidapak Services, LLC
Quantity
100 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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