Warfarin Sodium Tablets Recalled Due to Potential Labeling Error
Aidapak Services is recalling Warfarin Sodium 0.5 mg tablets that may be mislabeled as Sodium Chloride 1 mg tablets.
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 moderate severity.
Plain-English summary
Aidapak Services, LLC is recalling specific lots of Warfarin Sodium Tablet, 0.5 mg (1/2 of 1 mg), Rx only. The recall is due to a labeling error where these tablets may be mislabeled as SODIUM CHLORIDE, Tablet, 1 mg.
The affected product is identified by NDC 51672402701, Pedigree AD60590_4, and an expiration date of 5/29/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Patients and healthcare providers should check their medication labels. If the label indicates SODIUM CHLORIDE, Tablet, 1 mg, but the product is Warfarin Sodium, they should stop using the medication and contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- WARFARIN SODIUM Tablet, 0.5 mg (1/2 of 1 mg), Rx only, Distributed by: AidaPak Service, LLC, NDC 51672402701
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Anticoagulant
- Hazard
- Affected units
- 200
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 (3)
- WARFARIN SODIUM Tablet
- 0.5 mg (1/2 of 1 mg) has the following code Pedigree: AD60590_4
- EXP: 5/29/2014.
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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