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Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made...

FDA Recall #D-0317-2019 — Class II — November 20, 2018

Recall #D-0317-2019 Date: November 20, 2018 Classification: Class II Status: Ongoing

Product Description

Valsartan and Hydrochlorothiazide Tablets, USP, 320 mg/25 mg, (a) 500-count bottle, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505, U.S.A. NDC 0378-6325-05.

Reason for Recall

CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodiethylamine (NDEA) contained in the API used to manufacture the product.

Recalling Firm

Mylan Pharmaceuticals Inc. — Morgantown, WV

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

5,660 bottles

Distribution

Product was distributed throughout the United States.

Code Information

Lot # 3084886, exp. date 2/2019 Lot # 3093804, exp. date 12/2019

Status

Ongoing

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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