(KPLC) - Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets due to the detection of trace amounts of an unexpected impurity (NDEA) found in finished product, according to the FDA.
N-nitrosodiethylamine, or 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, says the FDA.
Here is the affected product:
- 33342-0052-10Macleods Pharmaceuticals LimitedLosartan Potassium/ Hydrochlorothiazide combination tablets 100mg/25mg, 90 count bottlesBLM715AJul -2019
Losartan Potassium/Hydrochlorothiazide combination tablets are indicated to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy, FDA says.
The FDA says Macleods Pharmaceuticals Limited has not received any reports of adverse events related to this recall. Patients taking this medication are urged to continue taking the medication as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment.