FDAClass IIISeptember 24, 2014

Candesartan Cilexetil and Hydrochlorothiazide Tablets recall: Impurity Out of Spec

Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles, Rx only, Manufactured by: Apotex Research Pvt. Ltd. Bangalore…

Why was Candesartan Cilexetil and Hydrochlorothiazide Tablets recalled?

Failed Impurity/Degradation Specification; high out of specification for CAD II degradant

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?

Lot # KK6086, exp 03/2015, UPC 360505375998.

Product
Candesartan Cilexetil and Hydrochlorothiazide Tablets 32 mg/12.5 mg, 90 count bottles, Rx only, Manufactured by: Apotex Research Pvt. Ltd. Bangalore…
Recalling firm
Apotex Corp.
Quantity
1,494 bottles
Distribution
Nationwide
Recall date
September 24, 2014
Classification
Class III
Status
Terminated
Agency
FDA (drug)
Open FDA enforcement record Latest recalls