FDA recall D-0317-2019

Product

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.

Distribution

Product was distributed throughout the United States.

Key facts

Status

Ongoing

Initiation date

2018-11-20

Report date

2018-12-19

Voluntary/Mandated

Voluntary: Firm initiated

Location

Morgantown, WV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0317-2019