FDA-Drug2019-03-27Class II
Valsartan Tablets 80 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 52343-123-90
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
37,410 bottles
Manufactured in
250 Pehle Ave Ste 601, N/A, Saddle Brook, NJ, United States
Products
Valsartan Tablets 80 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 52343-123-90
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1053-2019Don't want to check this manually?
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