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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- 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
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.
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