Mylan Laboratories Limited, (Nashik FDF) recalls Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bottle (NDC 0378-6324-77), (b) 500-count bottl…

Recall date

December 4, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0331-2019

FDA classification

Class II

Brand / firm

Mylan Laboratories Limited, (Nashik FDF)

Sold / distributed

Product was distributed throughout the United States to several major distributors, including Puerto Rico.

Why it was recalled

GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Valsartan and Hydrochlorothiazide Tablets, USP 320/12.5 mg, (a) 90-count bottle (NDC 0378-6324-77), (b) 500-count bottles (NDC 0378-6324-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.