US Drug Recall Register
Class II · Moderate risk Terminated Initiated Oct 29, 2018 (8 years ago)

Westminster Irbesartan Tablets, USP 150 mg Rx Only Manufactured by: ScieGen…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

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

Recalling firm
Westminster Pharmaceuticals Llc
NDC code
69367-120-01
Origin
MS, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0301-2019

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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