The FDA has announced that Macleods Pharmaceuticals Limited is voluntarily recalling one lot of its high blood pressure medications, Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg, due to trace amounts of an unexpected impurity (NDEA) detected in the finished product.
NDEA is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.
Macleods Pharmaceuticals is recalling the single lot because the NDEA traces found exceed FDA daily intake limits.
So far the FDA nor Macleods Pharmaceuticals have received reports of adverse effects or events related to the recalled medication.
Patients currently taking the medication are urged to continue taking it as the risk of harm to the patient may be greater if the treatment is stopped immediately without an alternative treatment.
The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.
The medication's information is:
Manufacturer: Macleods Pharmaceuticals
Product Description: LimitedLosartan Potassium/ Hydrochlorothiazide combination tablets 100mg/25mg, 90 count bottles
Lot/Batch Number: BLM715A; Expiration Date: Jul -2019
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