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Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count...

FDA Recall #D-0049-2021 — Class III — October 2, 2020

Recall #D-0049-2021 Date: October 2, 2020 Classification: Class III Status: Terminated

Product Description

Candesartan Cilexetil and Hydrochlorothiazide Tablets, USP 32 mg/12.5 mg, packaged in a) 90-count bottles (NDC 0378-3002-77) and b) 500-count bottles (NDC 0378-3002-05), Rx only, Manufactured for: Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.

Reason for Recall

Out-of-specification organic impurity results obtained during routine stability testing.

Recalling Firm

Mylan Pharmaceuticals Inc. — Morgantown, WV

Classification

Class III — Not likely to cause adverse health consequences.

Product Type

Drugs

Product Quantity

10,695 bottles

Distribution

Nationwide within the United States

Code Information

Lot #: a) 8095666, Exp. Date July 2021 b) 3104664, Exp. Date July 2021

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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