FDAClass IIJanuary 29, 2014

Triamterene/ Hydrochlorothiazide recall: Labeling Error

TRIAMTERENE/ HYDROCHLOROTHIAZIDE, Tablet, 37.5 mg/25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591042401.

Why was Triamterene/ Hydrochlorothiazide recalled?

Labeling: Label Mixup: TRIAMTERENE/ HYDROCHLOROTHIAZIDE, Tablet, 37.5 mg/25 mg may have potentially been mislabeled as the following drug: SEVELAMER HCL, Tablet 800 mg, NDC 58468002101, Pedigree: W002858, EXP: 6/7/2014.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

TRIAMTERENE/ HYDROCHLOROTHIAZIDE, Tablet, 37.5 mg/25 mg has the following codes: Pedigree: W002900, EXP: 6/10/2014.

Product
TRIAMTERENE/ HYDROCHLOROTHIAZIDE, Tablet, 37.5 mg/25 mg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00591042401.
Recalling firm
Aidapak Services, LLC
Quantity
100 Tablets
Distribution
Repacked drugs were distributed in Arizona, California, Oregon, and Washington.
Recall date
January 29, 2014
Classification
Class II
Status
Terminated
Agency
FDA (drug)
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