The Food and Drug Administration (FDA) has once again expanded its recall of common blood pressure drugs because of contamination with a chemical that is linked to cancer.
The agency’s announcement includes five additional lots of losartan, a generic drug manufactured by Torrent Pharmaceuticals Limited. The recalled lots include losartan potassium tablets as well as losartan potassium/hydrochlorothiazide tablets.
The tablets in the recalled lots contain trace amounts of N-methylnitrosobutyric acid, also known as NMBA. NMBA has been linked to cancer.
This is the fifth time Torrent Pharmaceuticals has expanded its recall of losartan, with the first recall happening in January. Several batches of generic ARBs have been recalled over the last year due to concerns of different contaminants.
Affected lots include:
- 13668-409-10 Losartan Potassium Tablets, USP 50mg, 1000 count. Batch number: 4DU2E009. Expiration date: 12/31/2020
- 13668-115-90 Losartan Potassium Tablets, USP 100mg, 90 count. Batch number: 4DU3E009. Expiration date: 12/31/2020
- 13668-115-10 Losartan Potassium Tablets, USP 100mg, 1000 count. Batch number: 4DU3E018. Expiration date: 02/28/2021
- 13668-116-90 Losartan Potassium/Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 count. Batch number: BEF7D051. Expiration date: 11/30/2020
- 13668-118-90 Losartan Potassium/Hydrochlorothiazide Tablets, USP 100mg/25mg, 90 count. Batch number: 4P04D007. Expiration date: 07/31/2020
Losartan is used to treat high blood pressure and hypertensive patients with Left Ventricular Hypertrophy. It is also used to treat diabetic nephropathy. The drug is a generic angiotensin II receptor blocker, also known as ARB.
The recall only impacts products that contain more than the FDA-allowable levels of NMBA.
The FDA has cautioned patients not to stop taking the drug, as the health risk is much higher than stopping treatment immediately without an alternative treatment. The agency advises patients to contact their physician or pharmacist to inquire about alternative treatment before returning their medication.
According to the FDA, Torrent Pharmaceuticals is notifying customers and distributors of the recall by phone and in writing. The company is arranging for recalled products to be returned to Qualanex. Torrent provides instructions on how to return the recalled products in the recall letter.
Consumers who have questions about the recall or want to report adverse events can do so by contacting Torrent Pharmaceuticals Limited at: 1-800-912-9561 or Medinfo.Torrent@apcerls.com. Representatives are available 8 am – 5 pm Eastern Time.