FDA-Drug2018-12-19Class II
Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-1721-93.
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
141,995 HDPE bottles
Manufactured in
F-4 F-12, Malegaon M.I.D.C., Sinnar, N/A, Sinnar, Nashik District, N/A, India
Products
Amlodipine and Valsartan Tablets, USP 5/160 mg, 30-count bottles, Rx Only, Made in India, Manufactured for: Mylan Pharmaceuticals, Inc., Morgantown, WV 26505 U.S.A. NDC 0378-1721-93.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0320-2019Don't want to check this manually?
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