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

Recall Number: D-0267-2019

Firm: Sciegen Pharmaceuticals Inc

Classification: Class II

Status: Terminated

Report Date: 20181128

Initiation Date: 20181029

Termination Date: 20230925

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