Losartan Potassium Tablets Recalled for Potential Label Mixup
Aidapak Services is recalling Losartan Potassium 25 mg tablets because they may have been mislabeled as Phytonadione 5 mg.
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 recall is classified as FDA Class II, which corresponds to a 'Severe' rating under the rubric, as it involves a potential label mixup that could lead to incorrect medication administration.
Plain-English summary
Aidapak Services, LLC is recalling Losartan Potassium, Tablet, 25 mg (NDC 00093736498) due to a potential label mixup. The recalled product may have been mislabeled as Phytonadione, Tablet, 5 mg (NDC 25010040515). The specific pedigree for the potentially mislabeled product is AD46312_22 with an expiration date of 4/30/2014.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. This recall is classified as Class II by the FDA, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
Patients and healthcare providers should check their medication labels to ensure they are taking the correct drug. If you have received a bottle labeled as Phytonadione 5 mg with pedigree AD46312_22, contact your pharmacist or healthcare provider for guidance on how to proceed.
The recalled product
- Product
- LOSARTAN POTASSIUM, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00093736498.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 90
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)
- LOSARTAN POTASSIUM
- Tablet
- 25 mg has the following codes: Pedigree: AD46312_16
- EXP: 5/16/2014.
Distribution
Part of a larger recall action
This product is one of 265 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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