Sciegen Pharmaceuticals Inc recalls GSMS Irbesartan Tablets, USP, 75 mg, 30-count bottle, Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge,

Recalled November 28, 2018 · FDA recall D-0270-2019 · Sciegen Pharmaceuticals

Hazard

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

Units

3,835 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, 75 mg, 30-count bottle, Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Marketed by: GSMS Incorporated Camarillo, CA 93012 USA, NDC 60429-640-90.

Manufacturer(s)

Sciegen Pharmaceuticals Inc

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