Blood pressure medication recalls are, unfortunately, becoming too common these days, and today we have another. The latest blood pressure medication recall comes from Torrent Pharmaceuticals who announced, via US Food and Drug Administration, that two lots of its popular Losartan potassium tablets are being voluntarily recalled. According to the statement, this recalls comes from the “detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited.”
This impurity is called N-nitrosodiethylamine (NDEA). It is naturally occurring in some foods but also present in air pollution, drinking water, and industrial processes. Unfortunately, the International Agency for Research on Cancer has classified NDEA as a probable human carcinogen.
You may recall a recent recall from Sandoz Inc. This issue was also over the presence of the NDEA impurity in its losartan potassium hydrochlorothiazide medication.
The recall includes:
- 30-count bottles of Losartan Potassium tablets, USP in the 100mg dosage in the lot/batch B031C016 with the expiration date of 04/2019
- 90-count bottles of Losartan Potassium tablets, USP in the 100mg dosage in the lot/batch B031C016 with the expiration date of 04/2019
- 100-count bottles of Losartan Potassium tablets, USP in the 100mg dosage in the lot/batch 4DK3C005 with the expiration date of 04/2019
Losartan potassium tablets are most commonly prescribed to treat high blood pressure, but the anti-hypertension drug has also been used for treating hypertension, and is particularly described to hypertension patients who have Left Ventricular Hypertrophy. It has also been prescribed to treat patients who have nephropathy from Type 2 diabetes.
It is very important to note, however, that the FDA recall advises patients who are taking Losartan should continue to do so because “the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment.” That in mind, then, it is crucial that patients should speak with either a pharmacist or with their physician to discuss potential alternative treatment options.
Of course, anyone who has questions or concerns about the recall—and especially anyone who may be experiencing side effects, reactions, or adverse events from this medicine can call 1.800.912.9561. And the FDA.gov is always available for more information on the recall, including additional points of contact.