Sciegen Pharmaceuticals Inc recalls Westminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 69367-120-01), (b) 90-count bottle (NDC 69367-120

Recalled November 28, 2018 · FDA recall D-0268-2019 · Sciegen Pharmaceuticals

Hazard

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

Units

5,061 HDPE bottles

Sold at

Nationwide

Description

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

Product

Westminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 69367-120-01), (b) 90-count bottle (NDC 69367-120-03), Rx Only, Manufactured by ScieGen Pharmaceuticals Inc. Hauppauge, NY 11755, Manufactured for Westminster Pharmaceuticals LLC Olive Branch, MS 20854, Made in the USA.

Manufacturer(s)

Sciegen Pharmaceuticals Inc

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