Aidapak Recalls Triamterene/Hydrochlorothiazide Tablets Due to Labeling Error
Aidapak Services, LLC is recalling Triamterene/Hydrochlorothiazide tablets because they may have been mislabeled as Sevelamer HCl.
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, which typically involves a labeling error that could cause temporary or medically reversible health consequences. The rubric assigns a score of 2 for minor labeling errors.
Plain-English summary
Aidapak Services, LLC is recalling Triamterene/Hydrochlorothiazide tablets, 37.5 mg/25 mg, NDC 00591-0424-01. The recall is due to a labeling error where the product may have been mislabeled as Sevelamer HCl tablets, 800 mg, NDC 58468-0021-01.
The affected product was distributed in Arizona, California, Oregon, and Washington. The specific lot identified has pedigree W002900 and an expiration date of 6/10/2014. The mislabeled product has pedigree W002858 and an expiration date of 6/7/2014.
Consumers and healthcare providers should check their inventory for this specific NDC and pedigree. If the product is found, it should be returned to the distributor or disposed of according to local regulations. Patients should consult their healthcare provider if they have questions about their medication.
The recalled product
- Product
- TRIAMTERENE/ HYDROCHLOROTHIAZIDE, Tablet, 37.5 mg/25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591042401.
- Manufacturer
- Aidapak Services, LLC
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 100
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)
- TRIAMTERENE/ HYDROCHLOROTHIAZIDE
- Tablet
- 37.5 mg/25 mg has the following codes: Pedigree: W002900
- EXP: 6/10/2014.
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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