FDA recall D-0268-2019

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.

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2018-10-29

Report date

2018-11-28

Termination date

2023-09-25

Voluntary/Mandated

Voluntary: Firm initiated

Location

Hauppauge, NY, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0268-2019