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In November 2018, Sandoz Inc. voluntarily recalled tablets of losartan potassium co-formulated with hydrochlorothiazide. The recall affects one lot of losartan potassium – hydrochlorothiazide 100 mg/25 mg 1,000-count bottles distributed after October 8, 2018. One of the raw ingredients, losartan, USP, made by Zhejiang Huahai Pharmaceutical Co. contains the contaminant N-nitrosodiethylamine (NDEA). In December 2018, Torrent recalled 2 lots of losartan potassium 100 mg tablets. The raw ingredient, losartan, USP, made by Hetero Labs Limited, contains the contaminant NDEA. The International Agency for Research on Cancer classifies NDEA as a probable human carcinogen. It is found naturally occurring in certain foods, drinking water, air pollution, and industrial processes. No adverse events have been reported at this time.
Pharmacies should cease distribution of, and quarantine all affected products. Return the recalled product per the instructions of each individual supplier. Patients should continue taking their medication until they can contact their healthcare provider to discuss alternative options. Patients with questions or concerns about this recall can contact Sandoz Inc. at 800-525-8747 or by email at usdrugsafety.operations@novartis.com; Torrent Pharmaceuticals by phone at 800-912-9561 or email at medinfo.torrent@apcerls.com. Consumers should report any adverse reactions from this product to their provider. Reactions may be reported to FDA through the MedWatch Adverse Event Reporting program at www.fda.gov/safety/medwatch/.
Additional information:
- Torrent Pharmaceuticals press release – December 20, 2018
www.fda.gov/Safety/Recalls/ucm628966.htm - Sandoz Inc. press release – November 8, 2018
www.fda.gov/Safety/Recalls/ucm625492.htm - FDA updates on angiotensin II receptor blocker (ARB) recalls
www.fda.gov/Drugs/DrugSafety/ucm613916.htm - FDA Q&A on impurities found in ARB products
www.fda.gov/Drugs/DrugSafety/ucm626122.htm