FDA Drug Recall Update: Losartan products

Date: 12/31/18

On December 31, 2018, the U.S. Food and Drug Administration (FDA) announced that Torrent Pharmaceuticals was expanding its voluntary recall of losartan products to a total of 10 lots.

The FDA press release states the following:
Torrent Pharmaceuticals Limited is expanding its voluntary recall from 2 lots of Losartan potassium tablets USP to a total of 10 lots, 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. Torrent is only recalling lots of losartan-containing products that contain N-nitrosodiethylamine (NDEA) above the acceptable daily intake levels released by the FDA. NDEA 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. To date, Torrent Pharmaceuticals Limited has not received any reports of adverse events related to this recall.

If you have any questions or concerns about Envolve Pharmacy Solutions’ response to the product recall, please contact Nelson Aragon, Pharm.D., Drug Utilization Review Clinical Pharmacist, at 800-225-2573, ext. 809-3034 or e-mail at Nelson.Aragon@Envolvehealth.com, or contact Taline Jaghasspanian, Pharm.D., Senior Manager, Clinical Pharmacy Operations, at 818-676-6959, or email at Taline.Jaghasspanian@Envolvehealth.com.

Read the Full FDA Announcement Here