FDA-Drug2018-12-19Class II
Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC 0378-6321-77), (b) 500-count bottles (NDC 0378-6321-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
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.
Sold states
Product was distributed throughout the United States to several major distributors, including Puerto Rico.
Affected count
32,696 HDPE bottles
Manufactured in
F-4 F-12, Malegaon M.I.D.C., Sinnar, N/A, Sinnar, Nashik District, N/A, India
Products
Valsartan and Hydrochlorothiazide Tablets, USP 80/12.5 mg, (a) 90-count bottle (NDC 0378-6321-77), (b) 500-count bottles (NDC 0378-6321-05), Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0328-2019Don't want to check this manually?
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