Recall: GSMS Incorporated Losartan Potassium 25 Mg And 100 Mg Tablets USP
On 2019-04-26, the FDA announced that Teva Pharmaceuticals USA is conducting a recall on Losartan Potassium 25 Mg And 100 Mg Tablets USP due to a possible . The recalled products were sold under the brand name(s) GSMS Incorporated during an unspecified time period throughout the regions shown in the map below.
In recent months, there have been 10 drugs recalls due to potential elevated impurity, including losartan potassium usp, losartan potassium tablets, usp, 25mg, 50mg, and 100mg and more. Additionally, there have been 19 drug and medical device recalls due to other health hazards as well as 69 food recalls.
Company Contact Information:
Name: Teva Pharmaceuticals USA
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Detailed Recall Information
Regions Where Sold: Nationwide
Product Description: Losartan Potassium 25 mg and 100 mg Tablets USP
Brand Name(s): GSMS Incorporated
Reason for Recall: N-Nitroso N-Methyl 4-amino butyric acid (NMBA) Impurity
Official Recall Date: 2019-04-26
Additional information provided by the FDA.gov:
Teva Pharmaceuticals USA, Inc. has initiated a voluntary recall in the United States, to the patient level, of 35 lots of bulk Losartan Potassium USP Tablets (6 lots of 25 mg strength and 29 lots of 100 mg strength). This recall is due to the detection of an impurity - N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) - found in six lots of active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited that is above the US Food & Drug Administration's interim acceptable exposure limit of 9.82 ppm. Based on the available information, the risk of developing cancer in a few patients following long-term use of the product cannot be ruled out. 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.