Westminster Irbesartan Tablets recalled over manufacturing violations

Recall date

October 29, 2018

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Westminster Pharmaceuticals Llc recalls Westminster Irbesartan Tablets, USP 75 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788 Ma…

Recall number

D-0300-2019

FDA classification

Class II

Brand / firm

Westminster Pharmaceuticals Llc

Sold / distributed

Nationwide.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Westminster Irbesartan Tablets, USP 75 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 69367-119-01; b) 90 count bottle NDC 69367-119-03