Drug Safety Alerts

MacLeod’s Pharmaceuticals Losratan Potassium and Losartan HCTZ Consumer-Level Recall

06/20/2019

On June 20, 2019, Macleods Pharmaceuticals issued a consumer-level recall of losartan potassium tablets and losartan and hydrochlorothiazide tablets. This recall was issued based on detection of trace amounts of an unexpected impurity found the finished product. The impurity detected is N-Nitroroso-N-Methyl-4-aminobutyric acid (NMBA). The impurity is a known animal and human carcinogen.

A complete list of the affected products and lot numbers is provided here:

Losartan is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients. Losartan and hydrochlorothiazide tablets, USP is used to treat hypertension and hypertensive patients with Left Ventricular Hypertrophy. Patients who are on losartan potassium tablets and losartan potassium and hydrochlorothiazide tablets should continue taking their medication, as the risk of harm to the patient’s health may be higher if the treatment is stopped immediately without any alternative treatment. Patients should contact their pharmacist or physician who can advise them about an alternative treatment prior to returning their medication.

CVS Caremark Response:

Please note: These products are not carried by the CVS Caremark Mail Service Pharmacies.

For more information about this recall, Macleods has asked that health care providers contact Qualanex at 1‑888-280-2046, Monday through Friday, 7:00 am to 4:00 pm (CT) or email them at recall@qualanex.com. You may also contact the FDA at 1‑888‑INFO-FDA (1‑888-463-6332) or visit at www.fda.gov.