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GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle...

FDA Recall #D-0271-2019 — Class II — October 29, 2018

Recall #D-0271-2019 Date: October 29, 2018 Classification: Class II Status: Terminated

Product Description

GSMS Irbesartan Tablets, USP, 150 mg, (a) 30-count bottle (NDC 60429-641-30), (b) 90-count bottle (NDC 60429-641-90), Rx Only, Manufactured by ScieGen Pharmaceuticals, Inc. Hauppauge, NY 11788, Marketed by: GSMS Incorporated Camarillo, CA 93012 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

18,760 HDPE bottles

Distribution

Nationwide

Code Information

60429-641-90 Irbesartan 150mg Tablets, 90 Count Bottle B161003 Sep-19 B161004 Sep-19 B161006 Sep-19 B161007 Sep-19 B161008 Nov-19 B161009 Nov-19 B161010 Nov-19 C161001 Feb-20 C161003 May-20 60429-641-30 Irbesartan 150mg Tablets, 30 Count Bottle GS019526 Nov-19 GS020252 Nov-19 GS020958 Nov-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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