Losartan and Losartan/HCTZ market withdrawal – Jubilant Cadista Pharmaceuticals

Updated: 9/17/21

On September 13, 2021, Jubilant Cadista Pharmaceuticals announced a market withdrawal of all unexpired lots of Losartan Potassium as well as Losartan Potassium and Hydrochlorothiazide distributed under the Cadista label. This market withdrawal is being carried out due to the presence of a potential azido impurity, 5-(4'-(azidomethyl)-[1,1'-biphenyl]-2yl)-1H-tetrazole, in the finished drug product dosage. Azido is considered a mutagen, which is a chemical substance that can cause a change in the DNA of a cell. These mutations may increase the risk of cancer, but the specific risk for this azido impurity to cause cancer in humans is unknown. To date, no reports of adverse events related to this drug product withdrawal have been reported to Jubilant Cadista.

What do I need to know?

• Express Scripts will mail letters to patients who have received medication impacted by the market withdrawal.
• Losartan potassium-containing products are used to treat high blood pressure, hypertensive patients with left ventricular hypertrophy, and nephropathy in Type 2 diabetic patients. Therefore, it is important you do not stop or change how you are taking your medication without consulting your prescriber, as the risk of harm to your health may be higher if the medication is stopped immediately without any alternative treatment. If you have medical or health concerns, contact your prescriber.
• Because this is an all-lot drug product market withdrawal, a market shortage of Jubilant Cadista-manufactured drug product has occurred. Express Scripts is working to secure drug product from other manufacturers for filling future prescriptions.
• For impacted patients, if you specifically requested the Jubilant Cadista product be used to fill your prescriptions, please contact your prescriber to discuss other treatment options. Otherwise, your next fill will be processed using drug product that is not affected by a drug product market withdrawal. If you want a new supply now, please order your prescription by going online to esrx.com or calling the toll-free number on your prescription bottle. If your prescription has no refills remaining, please contact your prescriber for a new prescription.
• Please be aware that Jubilant Cadista has not provided a way to return or obtain reimbursement for the withdrawn drug product at this time. Therefore, neither are we, as your home delivery pharmacy, able to accept returns or credit your account for the withdrawn drug product.
• For medical questions concerning the withdrawn drug product, please contact your prescriber or Jubilant Cadista Pharmaceuticals Inc. at 800.308.3985.

You can also report adverse events or quality problems related to the use of the drug to the FDA’s MedWatch Adverse Events Reporting Program. Call 800.FDA.1088 or go to https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program