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Westminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 69367-120-01), (b) 90-coun...

FDA Recall #D-0268-2019 — Class II — October 29, 2018

Recall #D-0268-2019 Date: October 29, 2018 Classification: Class II Status: Terminated

Product Description

Westminister Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 69367-120-01), (b) 90-count bottle (NDC 69367-120-03), Rx Only, Manufactured by ScieGen Pharmaceuticals Inc. Hauppauge, NY 11755, Manufactured for Westminster 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

5,061 HDPE bottles

Distribution

Nationwide

Code Information

69367-120-01 Irbesartan 150mg Tablets, 30 count bottle B161005A Sep-19 C161002A Feb-20 69367-120-03 Irbesartan 150mg Tablets, 90 count bottle B161005B Sep-19 C161002B Feb-20

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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