Valsartan Tablets 80 mg USP recalled over manufacturing violations

Recall date

March 7, 2019

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Rising Pharmaceuticals, Inc. recalls Valsartan Tablets 80 mg USP, 90 tablet bottles, Rx only, Distributed by: Acetris Health, LLC, Saddle Brook, NJ 07663, M…

Recall number

D-1053-2019

FDA classification

Class II

Brand / firm

Rising Pharmaceuticals, Inc.

Sold / distributed

Product was distributed to 6 major distributors who may have further distributed the product throughout the United States.

Why it was recalled

CGMP Deviations; Detection of a trace amount of unexpected impurity N- nitrosodiethylamine (NDEA) found in finished products

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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