Expanded Blood Pressure Medication Recall 2019: What Medication Is Affected?

Torrent Pharmaceuticals Limited (TORNTPHARM.NS) has expanded its recall of 10 lots of Losartan potassium tablets USP to include six additional lots of Losartan potassium and hydrochlorothiazide tablets, USP. The recalled medication may have trace amounts of an impurity know as N-nitrosodiethylamine (NDEA), which could cause cancer.

The NDEA impurity is found in certain foods, drinking water, air pollution, and industrial processes. It was classified as a probable carcinogen by the International Agency for Research on Cancer.

A full list of recalled medication can be found here. The medication can be identified by checking the product name, manufacturer details, and batch or lot number on the bottle of the product. The medication was manufactured by Hetero Labs Limited and was distributed nationwide.

The company is only recalling the lots of Losartan that have NDEA above the acceptable daily limit recommended by the U.S. Food and Drug Administration (FDA). Torrent, which issued the voluntary recall in conjunction with the FDA, has not received any adverse reports from the recalled medication to date.​

Losartan is used to treat hypertension, hypertensive patients with left ventricular hypertrophy, and for the treatment of nephropathy in Type 2 diabetes patients.

Torrent Pharmaceuticals is urging consumers to talk to their physician or pharmacist about an alternative treatment plan. Patients should continue taking the recalled medication until an alternate treatment is provided as the risk of harm is greater if a patient stops without alternative treatment. If a consumer is having issues with the medication, they should contact their healthcare provider.

Consumers with medical questions regarding the recalled medication can call Torrent Pharmaceuticals at 1-800-912-9561 from 8 a.m. to 5 p.m. ET. Voicemail is available 24 hours a day, seven days a week. Email for the company is Medinfo.Torrent@apcerls.com.

Returns of the recalled medication should be directed to Qualanex at 1-888-280-2040 from 8 a.m. to 9 p.m. ET.

Adverse reactions or quality issues from the recalled medication can be reported to the FDA’s MedWatch Adverse Event Reporting program by phone, online, fax or mail. Online forms can be completed at www.fda.gov/medwatch/report.htm. To receive a form to fax or mail visit www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088. The fax number is 1-800-FDA-0178.

Shares of Torrent Pharmaceutical were down 8.45 percent as of 10:40 a.m. on Wednesday.