Sciegen Pharmaceuticals Inc recalls Westminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC 69367-121-01, (b) 90-count bottle (NDC 693
Recalled November 28, 2018 · FDA recall D-0269-2019 · Sciegen Pharmaceuticals
Hazard
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product. · FDA Class II
Units
5,989 HDPE
Sold at
Nationwide
Description
CGMP Deviations: FDA laboratory testing confirmed presence of an impurity, N-nitrosodimethylamine (NDEA) in product.
Product
Westminister Irbesartan Tablets, USP, 300mg, Rx Only,(a) 30-count bottle (NDC 69367-121-01, (b) 90-count bottle (NDC 69367-121-03), 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 →