Mylan Laboratories Limited, (Nashik FDF) recalls Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle (NDC 0378-6323-77), (b) 500-count bottles
Recalled December 19, 2018 · FDA recall D-0330-2019 · Mylan Laboratories Limited, (Nashik FDF)
Hazard
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product. · FDA Class II
Units
22,813 HDPE bottles
Sold at
Product was distributed throughout the United States to several major distributors, including Puerto Rico.
Description
GCMP Deviations: FDA analysis confirmed presence of trace amounts of an impurity, N-nitrosodiethylamine (NDEA) found in the API used to manufacture the product.
Product
Valsartan and Hydrochlorothiazide Tablets, USP 160/25 mg, (a) 90-count bottle (NDC 0378-6323-77), (b) 500-count bottles (NDC 0378-6323-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
Manufacturer(s)
Mylan Laboratories Limited, (Nashik FDF)
Made in
India
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →