Recall: ScieGen Pharmaceuticals, Inc Irbesartan Tablets, USP 75 Mg, 150 Mg, And 300 Mg Dosage Forms
On 2018-10-26, the FDA announced that Aurobindo Pharma Limited is conducting a recall on Irbesartan Tablets, USP 75 Mg, 150 Mg, And 300 Mg Dosage Forms due to a possible n-nitrosodiethylamine (ndea). The recalled products were sold under the brand name(s) ScieGen Pharmaceuticals and Inc during an unspecified time period throughout the regions shown in the map below.
In recent months, there have been 4 drugs recalls due to potential elevated impurity, including valsartan/amlodipine/hctz, valsartan/amlodipine and valsartan tablets, valsartan/amlodipine/hctz tablets and more. Additionally, there have been 23 drug and medical device recalls due to other health hazards as well as 77 food recalls.
Company Contact Information:
Name: Aurobindo Pharma Limited
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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, USP 75 mg, 150 mg, and 300 mg dosage forms
Brand Name(s): ScieGen Pharmaceuticals, Inc
Reason for Recall: Elevated Impurity of N-nitrosodiethylamine (NDEA)
Official Recall Date: 2018-10-26
Additional information provided by the FDA.gov:
Aurobindo Pharma Limited is voluntarily recalling 22 Batches of the drug substance Irbesartan due to the presence of an impurity, N-nitrosodiethylamine (NDEA). The 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.