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Home > Recalled Products > Drugs > Elevated Impurity > GSMS Inc. Losartan Potassium Tablets

Recall: GSMS Inc. Losartan Potassium Tablets

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On 2019-06-10, the FDA announced that Teva Pharmaceuticals USA is conducting a recall on Losartan Potassium Tablets due to a possible . The recalled products were sold under the brand name(s) GSMS Inc. during an unspecified time period throughout the regions shown in the map below.

In recent months, there have been 6 drugs recalls due to potential elevated impurity, including losartan potassium 25 mg and 100 mg tablets usp, losartan potassium usp and more. Additionally, there have been 21 drug and medical device recalls due to other health hazards as well as 67 food recalls.

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LOSARTAN POTASSIUM 50 mg TABLETS 30 tablets/bottle, Label
Note: Images may not be available for every version. Please review the detailed description below.

Company Contact Information:

Name: Teva Pharmaceuticals USA
Website: www.tevapharm.com
Phone: 888-838-2872

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Detailed Recall Information



Regions Where Sold: California

Product Description: Losartan potassium tablets

Brand Name(s): GSMS Inc.

Reason for Recall: Elevated Impurity of N-Nitroso-N-methyl-4-aminobutyric acid (NMBA)

Official Recall Date: 2019-06-10


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Additional information provided by the FDA.gov:

Teva Pharmaceuticals USA, Inc. has expanded its voluntary consumer-level recall originally initiated on April 25, 2019 in the United States of losartan potassium tablets. This expanded recall includes six (6) lots of bulk losartan potassium USP Tablets (two lots of 50 mg strength and four lots of 100 mg strength) due to the detection of an impurity - N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) - that is above the US Food & Drug Administration's interim acceptable exposure limit of 9.82 ppm. The source of the NMBA impurity was detected in one lot of active pharmaceutical ingredient (API), manufactured by Hetero Labs Limited, which was used in the manufacturing of the six (6) bulk lots of these drug products. Based on the available information, there is a potential risk of developing cancer in a few patients following long-term use of products containing high levels of NMBA. 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.

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