FDA recall D-0301-2019

Westminster Pharmaceuticals Llc · Class II · drug

Product

Westminster Irbesartan Tablets, USP 150 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Manufactured for: Westminster Pharmaceuticals, LLC. Olive Branch, MS 38654 a) 30 count bottle NDC 69367-120-01; b) 90 count bottle NDC 69367-120-03

Reason for recall

CGMP Deviations: FDA laboratory testing confirmed traces of NDEA impurity in specific lots of Irbesartan.

Distribution

Nationwide.

Key facts

Status: Terminated
Initiation date: 2018-10-29
Report date: 2018-12-19
Termination date: 2021-10-26
Voluntary/Mandated: Voluntary: Firm initiated
Location: Olive Branch, MS, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0301-2019