Recall: Westminster Pharmaceuticals and Golden State Medical Supply Irbesartan Tablets
On 2018-10-30, the FDA announced that ScieGen Pharmaceuticals is conducting a recall on Irbesartan Tablets due to a possible ndea (n-nitrosodiethylamine). The recalled products were sold under the brand name(s) Westminster Pharmaceuticals and Golden State Medical Supply during an unspecified time period throughout the regions shown in the map below.
In recent months, there have been 5 drugs recalls due to potential elevated impurity, including irbesartan tablets, usp 75 mg, 150 mg, and 300 mg dosage forms, valsartan/amlodipine/hctz, valsartan/amlodipine and valsartan tablets and more. Additionally, there have been 21 drug and medical device recalls due to other health hazards as well as 79 food recalls.
Company Contact Information:
Name: ScieGen Pharmaceuticals
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Detailed Recall Information
Regions Where Sold: Because the region was not specified, it is assumed that this product was available nationwide.
Product Description: Irbesartan Tablets
Brand Name(s): Westminster Pharmaceuticals and Golden State Medical Supply
Reason for Recall: NDEA (N-Nitrosodiethylamine) Impurity
Official Recall Date: 2018-10-30
Additional information provided by the FDA.gov:
ScieGen Pharmaceuticals, Inc. is voluntarily recalling listed lots, within expiry, of Irbesartan Tablets, USP 75 mg, 150 mg, and 300 mg dosage forms to the consumer level. These products are being recalled due to the presence of an impurity, N-nitrosodiethylamine (NDEA) contained in the API Irbesartan, USP manufactured by Aurobindo Pharma Limited. This impurity, which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) Read More.
More information may be available at FDA.gov
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Sources may include Food & Drug Administration (FDA), United States Department of Agriculture (USDA), Health Canada and companies involved with this or a related recall.