Recall: Macleods Losartan Potassium USP Tablets And Losartan Potassium/Hydrochlorothiazide Combination Tablets
On 2019-06-26, the FDA announced that Macleods Pharmaceutical Limited is conducting a recall on Losartan Potassium USP Tablets And Losartan Potassium/Hydrochlorothiazide Combination Tablets due to a possible . The recalled products were sold under the brand name(s) Macleods 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 losartan potassium tablets, losartan potassium 25 mg and 100 mg tablets usp and more. Additionally, there have been 18 drug and medical device recalls due to other health hazards as well as 66 food recalls.
Company Contact Information:
Name: Macleods Pharmaceutical Limited
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Detailed Recall Information
Regions Where Sold: Nationwide
Product Description: Losartan Potassium USP tablets and Losartan Potassium/Hydrochlorothiazide combination tablets
Brand Name(s): Macleods
Reason for Recall: NMBA impurity
Official Recall Date: 2019-06-26
Additional information provided by the FDA.gov:
Macleods Pharmaceuticals Limited has initiated a voluntary recall in the United States, to the patient level, of 32 lots of Losartan Potassium USP Tablets (2 lots of 50mg strength) and Losartan Potassium/Hydrochlorothiazide combination Tablets (12 lots of 50mg/12.5mg strength, 3 lots of 100mg/12.5mg strength and 15 100mg/25mg strength) to the patient level due to the detection of trace amounts of an unexpected impurity, N-Nitroso-N-methyl-4-aminobutyric acid (NMBA). The impurity was found in 32 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.