Losartan and Losartan with Hydrochlorothiazide recall (Torrent)

On December 20th 2018, Torrent Pharmaceuticals Limited announced a voluntary recall of 2 lots of Losartan potassium tablets, USP to the consumer level due to the detection of trace amounts of an unexpected impurity found in an active pharmaceutical ingredient (API) manufactured by Hetero Labs Limited. The recall was expanded to a total of 10 lots on January 3rd, 2019. The impurity detected in the API is N-nitrosodiethylamine (NDEA), which is a substance that occurs naturally in certain foods, drinking water, air pollution, and industrial processes, and has been classified as a probable human carcinogen as per International Agency for Research on Cancer (IARC) classification.

On 2/28/19, Torrent announced an additional recall to include additional lots due to detection of trace amounts of the impurity N-Methylnitrosobutyric acid (NMBA), with additional lots added on 4/18/19.

To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall.

Losartan is used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and for the treatment of nephropathy in Type 2 diabetic patients. Patients who are on Losartan 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.

What is being recalled?

• Losartan Potassium Tablets (25mg, 50mg and 100mg) and Losartan/Hydrochlorothiazide (50/12.5mg and 100/12.5mg, and 100/25mg) by Torrent Pharmaceuticals. Only specific NDC/Lot numbers are being recalled.
• You can find general information regarding these recalls, including impacted NDC/Lot numbers, on the FDA website:
  https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/torrent-pharmaceuticals-limited-expands-voluntary-nationwide-recall-losartan-potassium-tablets-usp
  https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/updated-torrent-pharmaceuticals-limited-issues-voluntary-nationwide-recall-losartan-potassium
  https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/updated-torrent-pharmaceuticals-limited-expands-voluntary-nationwide-recall-losartan-potassium

What do I need to know?

• Express Scripts will mail letters to patients who have received medication impacted by the recall.
• General questions regarding the recall (including returns) may be directed to Qualanex at 1-888-280-2040 (live calls received 8:00 am – 9:00 pm Eastern Time)
• The Food and Drug Administration has stated that patients who have the recalled medicine should continue taking it until they have a new supply unless otherwise directed by their healthcare provider, as the risk of harm to the your health may be higher if the treatment is stopped immediately without any alternative treatment.
  • Please consult with your prescriber for guidance on continuing to take this medication or if you should obtain a new prescription for an alternative therapy.
  • If you and your prescriber decide you should continue to take the medication on hand, your next fill will be processed using medication that is not part of any existing recall.
  • If you choose to stay on this therapy but need to obtain a fresh supply and it is not time for your next refill, please call us at the toll free number on your prescription bottle to request an early refill. Your order will be filled with medication that is not part of any existing recall.

Why was this medication recalled?

• This voluntary recall is being issued by Torrent working with the FDA because an impurity(either N-Nitrosodiethylamine (NDEA) or N-Methylnitrosobutyric acid (NMBA) was detected in the recalled lots.
• Any suspected adverse events that may be related to the use of these products should be reported to your doctor. You can also report adverse events that may be related to this recall to FDA's Med Watch Program either online, by regular mail or by fax.
• Online: https://www.accessdata.fda.gov/scripts/medwatch/index.cfm?action=reporting.home
• Regular Mail: Use postage-paid, pre-addressed Form FDA 3500B available at: http://www.fda.gov/MedWatch/getforms.htm. Mail to the address on the pre-addressed form.
• Fax: 1-800-332-0178 (toll free)