FDAClass IIJanuary 29, 2014

Levothyroxine Sodium recall: Labeling Error

LEVOTHYROXINE SODIUM, Tablet, 175 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00527135001.

Why was Levothyroxine Sodium recalled?

Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 175 mcg may have potentially been mislabeled as one of the following drugs: LEVOTHYROXINE SODIUM, Tablet, 88 mcg, NDC 00781518392, Pedigree: AD46265_34, EXP: 5/15/2014; hydrOXYzine PAMOATE, Capsule, 100 mg, NDC 00555032402, Pedigree: W003008, EXP: 6/11/2014.

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?

LEVOTHYROXINE SODIUM, Tablet, 175 mcg has the following codes: Pedigree: AD46265_37, EXP: 5/15/2014; Pedigree: W003009, EXP: 6/11/2014.

Product
LEVOTHYROXINE SODIUM, Tablet, 175 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00527135001.
Recalling firm
Aidapak Services, LLC
Quantity
200 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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