FDA Recalls Potentially Mislabeled Losartan Potassium Tablets
Aidapak Services is recalling Losartan Potassium tablets that may be mislabeled as Disopyramide Phosphate. The error involves a label mixup on repacked drugs.
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, particularly given the risk of administering the wrong medication.
Plain-English summary
Aidapak Services, LLC is recalling Losartan Potassium, Tablet, 25 mg (NDC 13668011390) due to a labeling error. The recall is classified as FDA Class II.
The issue is a label mixup where the Losartan Potassium tablets may be potentially mislabeled as Disopyramide Phosphate, Capsule, 150 mg (NDC 00093312901). The affected product has the pedigree AD65323_10 and an expiration date of 5/29/2014. The mislabeled product is identified by pedigree AD65323_4.
The repacked drugs were distributed in Arizona, California, Oregon, and Washington. Consumers and healthcare providers should check their inventory for this specific NDC and pedigree. If found, the product should be returned to the distributor or disposed of according to local regulations.
The recalled product
- Product
- LOSARTAN POTASSIUM, Tablet, 25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 13668011390
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 180
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 code Pedigree: AD65323_10
- 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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