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Westminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-119-01), (b) 90-count ...

FDA Recall #D-0267-2019 — Class II — October 29, 2018

Recall #D-0267-2019 Date: October 29, 2018 Classification: Class II Status: Terminated

Product Description

Westminister Irbesartan Tablets, USP, 75 mg (a) 30-count bottle (NDC 69367-119-01), (b) 90-count bottle (NDC 69367-119-03), Rx Only, Manufactured by ScieGen Pharmaceuticals Inc Hauppauge, NY 11755 Manufactured for Westminister 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.

Recalling Firm

Sciegen Pharmaceuticals Inc — Hauppauge, NY

Classification

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

Product Type

Drugs

Product Quantity

2,977 HDPE bottles

Distribution

Nationwide

Code Information

69367-119-01 Irbesartan 75mg Tablets, 30 count bottle B160002A Sep-19 69367-119-03 Irbesartan 75mg Tablets, 90 count bottle B160002B Sep-19

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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