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Westminster Irbesartan Tablets, USP 300 mg Rx Only Manufactured by: ScieGen Pharmaceuticals, Inc....

FDA Recall #D-0302-2019 — Class II — October 29, 2018

Recall #D-0302-2019 Date: October 29, 2018 Classification: Class II Status: Terminated

Product Description

Westminster Irbesartan Tablets, USP 300 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 69367-121-01; b) 90 count bottle NDC 69367-121-03

Reason for Recall

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

Recalling Firm

Westminster Pharmaceuticals Llc — Olive Branch, MS

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

3976 bottles

Distribution

Nationwide.

Code Information

Batch Numbers: a) B162008A Exp. 09/30/2019, C162002A Exp. 02/29/2020; b) B162008B Exp. 09/30/2019, C162002B Exp. 02/29/2020

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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