Recall: Macleods Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg
On 2019-02-22, the FDA announced that Macleods Pharmaceuticals Limited is conducting a recall on Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg due to a possible ndea (n-nitrosodiethylamine) . 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 5 drugs recalls due to potential elevated impurity, including irbesartan and irbesartan hctz tablets, losartan potassium tablets usp and more. Additionally, there have been 14 drug and medical device recalls due to other health hazards as well as 78 food recalls.
Company Contact Information:
Name: Macleods Pharmaceuticals 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: Losartan Potassium/Hydrochlorothiazide Combination Tablets 100mg/25mg
Brand Name(s): Macleods
Reason for Recall: NDEA (N-Nitrosodiethylamine) Impurity
Official Recall Date: 2019-02-22
Additional information provided by the FDA.gov:
Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg to the consumer level due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product manufactured with active pharmaceutical ingredient made by Hetero Labs Limited. 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.