Drug Safety Alerts

AvKARE Losartan Potassium Tablets and Losartan Potassium and Hydrochlorothiazide Tablets Consumer-Level Recall

03/04/2019

On March 4, 2019, AvKARE issued a consumer-level recall of losartan potassium tablets and losartan potassium and hydrochlorothiazide tablets manufactured by Torrent that were repackaged and distributed by AvKARE. This recall was issued due to the detection of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The impurity detected in the API is N‐Methylnitrosobutyric acid (NMBA).

A complete list of the affected products 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 potassium 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:

The repackaged product distributed by AvKARE is not carried by the CVS Caremark Mail Service Pharmacies.

For more information about this recall, please contact AvKARE at 1-855-628-5273 (1-855-6AV-KARE). For more information regarding the Torrent losartan-containing products recall, please contact theFDA consumer inquiry line at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit www.fda.gov.