Sciegen Pharmaceuticals Inc recalls Westminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-119-01), (b) 90-count bottle (NDC 69367-119-0

Recalled November 28, 2018 · FDA recall D-0267-2019 · Sciegen Pharmaceuticals

Hazard

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

Units

2,977 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, 75 mg (a) 30-count bottle (NDC 69367-119-01), (b) 90-count bottle (NDC 69367-119-03), Rx Only, Manufactured by ScieGen Pharmaceuticals Inc Hauppauge, NY 11755 Manufactured for Westminister 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 →