Rising Pharmaceuticals, Inc. recalls Valsartan Tablets 160 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, M
Recalled March 27, 2019 · FDA recall D-1054-2019 · Rising Pharmaceuticals
Hazard
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products · FDA Class II
Units
35,281 bottles
Sold at
Product was distributed to 6 major distributors who may have further distributed the product throughout the United States.
Description
CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products
Product
Valsartan Tablets 160 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, Manufactured by: Aurolife Pharma LLC, Dayton, NJ 08810 ---- NDC 52343-124-90
Manufacturer(s)
Rising Pharmaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →