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

Recalled November 28, 2018 · FDA recall D-0272-2019 · Sciegen Pharmaceuticals

Hazard

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

Units

30,194 HDPE bottles

Sold at

Nationwide

Description

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

Product

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.

Manufacturer(s)

Sciegen Pharmaceuticals Inc

Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →