Warfarin Sodium Tablets Recalled Due to Potential Label Mixup
Aidapak Services is recalling Warfarin Sodium 0.5 mg tablets because they 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, FDA Class II recalls involving significant injury or property damage reports, or structural defects, are rated Severe (4). While no specific injuries are reported in the text, the mislabeling of a potent anticoagulant as a saline tablet poses a significant risk of serious harm, aligning with the Severe criteria for high-risk medication errors.
Plain-English summary
Aidapak Services, LLC is recalling Warfarin Sodium Tablets, 0.5 mg (1/2 of 1 mg), NDC 51672402701. The recall is due to a labeling error where the product may be mislabeled as Sodium Chloride Tablets, 1 mg, NDC 00223176001.
The affected product has the pedigree AD60590_4 and an expiration date of 5/29/2014. The repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Consumers and healthcare providers should check their inventory for this specific product and stop using it if it matches the description. They should contact their pharmacist or the recalling firm for further instructions.
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 (4)
- 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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