The Recall Desk
ModerateFDA (Drugs)·D-698-2014·Announced 2014-01-22

FDA Recalls Mislabeled Febuxostat Tablets Due to Label Mixup

Aidapak Services is recalling Febuxostat 40 mg tablets that may be mislabeled as other medications due to a labeling error.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II and involves a labeling error (label mixup) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.

Plain-English summary

Aidapak Services, LLC is recalling Febuxostat Tablet, 40 mg, NDC 64764091830, due to a labeling error. The recall is initiated because the product may be potentially mislabeled as methylPREDNISolone Tablet, 4 mg, tiZANidine HCl Tablet, 2 mg, or SODIUM CHLORIDE Tablet, 1000 mg.

The repacked drugs were distributed in Arizona, California, Oregon, and Washington. The affected product includes 300-tablet packages with specific pedigree and expiration codes listed in the recall notice.

Consumers should check their medication labels and contact their healthcare provider or pharmacist if they have the affected product. Do not take the medication if the label does not match the prescription.

The recalled product

Product
FEBUXOSTAT Tablet, 40 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 64764091830
Affected units
300

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (7)

  • FEBUXOSTAT Tablet
  • 40 mg has the following codes Pedigree: AD23082_16
  • EXP: 11/1/2013
  • Pedigree: W002664
  • EXP: 6/5/2014
  • Pedigree: W003927
  • EXP: 7/1/2014.

Distribution

Distributed in 4 states:

Part of a larger recall action

This product is one of 273 recalled by Aidapak Services, LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 273 products in this recall →

Same manufacturer · Aidapak Services, LLC

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