Expanded Blood Pressure Medication Recall: Everything You Need To Know

Torrent Pharmaceuticals Limited (TORNTPHARM.NS) has expanded its blood pressure medication recall to include 10 lots of Losartan potassium tablets USP. This is an increase from the two lots recalled in December. The updated recall was made in conjunction with the U.S. Food and Drug Administration (FDA).

The blood pressure medication is being recalled because of a potential cancer-causing impurity – nitrosdiethylamine (NDEA). The NDEA level found in the Losartan potassium tablets USP is above the acceptable daily intake level released by the FDA.

The NDEA was detected in trace amounts and was manufactured by the Hetero Labs Limited. Torrent is only recalling the lots of Losartan potassium tablets USP that contain NDEA levels higher than the FDA’s guideline.

NDEA is a naturally occurring substance that is found in some foods, drinking water, air pollution, and industrial processes. The International Agency for Research on Cancer has classified it as a probable carcinogen.

Losartan potassium tablets USP are used to treat hypertension, hypertensive patients with Left Ventricular Hypertrophy and nephropathy in Type 2 diabetic patients. A full list of recalled medication can be found here.

The recalled product was packaged in bottles and can be identified by checking the product name, manufacturer details, and batch or lot number on the bottle. The recalled medication was distributed nationwide to distributors, repackagers, and retail customers.

Torrent is urging patients that take the recalled blood pressure medication to continue taking it as prescribed as the risk of stopping it without alternative treatment could cause greater harm. Consumers should contact their physician or healthcare provider if they have any problems associated with taking the medication.

Consumers with medical questions about the recalled medication can contact Torrent at 1-800-912-9561 from 8 a.m. to 5 p.m. EST. Voicemail is available 24 hours a day, seven days a week. Adverse reactions to the medication can be directed to the same number. Email for the company is Medinfo.Torrent@apcerls.com.

General questions about the return of the recalled blood pressure medications can be directed to Qualanex at 1-888-280-2040 from 8 a.m. to 9 p.m. EST.

Adverse reaction or quality issues with the medication can be reported to the FDA’s MedWatch Adverse Event Reporting program. Forms can be completed and submitted online at www.fda.gov/medwatch/report.htm. Forms to mail or fax can be obtained at www.fda.gov/MedWatch/getforms.htm or by calling 1-800-332-1088. Fax number is 1-800-FDA-0178.

As of this morning, Torrent stock was up 0.64 percent.