FDA-Drug2019-03-27Class II
Valsartan Tablets 40 mg USP, 30 tablet bottles, Rx, Only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ, Manufactured by: Aurolife Pharma LLC, Dayton, NJ ---- NDC 52343-122-30
Rising Pharmaceuticals, Inc.
Hazard
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Sold states
Product was distributed to 6 major distributors who may have further distributed the product throughout the United States.
Affected count
30,530 bottles
Manufactured in
250 Pehle Ave Ste 601, N/A, Saddle Brook, NJ, United States
Products
Valsartan Tablets 40 mg USP, 30 tablet bottles, Rx, Only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ, Manufactured by: Aurolife Pharma LLC, Dayton, NJ ---- NDC 52343-122-30
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1052-2019Don'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