GSMS Irbesartan Tablets recalled over manufacturing violations

Recall date

October 29, 2018

Source

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

Official notice title

Sciegen Pharmaceuticals Inc recalls GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90), Rx…

Recall number

D-0272-2019

FDA classification

Class II

Brand / firm

Sciegen Pharmaceuticals Inc

Sold / distributed

Nationwide

Why it was recalled

CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.

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

What was recalled

GSMS Irbesartan Tablets, USP, 300 mg,(a) 30-count bottle (NDC 60429-642-30), (b) 90-count bottle (NDC 60429-642-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 USA.