FDA-Drug2019-01-23Class II
Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-550-90.
Aurobindo Pharma USA Inc.
Hazard
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
Sold states
Product was distributed to 25 distributors and Retail Chains who may have further distributed the product throughout the United States.
Affected count
23,016 bottles
Manufactured in
279 Princeton Hightstown Rd, East Windsor, NJ, United States
Products
Valsartan and Hydrochlorothiazide tablets USP 320mg/12.5 mg, 90-count bottle, Rx Only, Manufactured for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. NDC 65862-550-90.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0365-2019Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief