Two more additional blood pressure medications have come under voluntary recalls during the last two weeks, according to the U.S. Food and Drug Administration.
The FDA announced Oct. 30 that ScieGen Pharmaceuticals has placed voluntary recalls on its irbesartan tablets in 75-, 150-, and 300-milligram dosage forms packed in 30- and 90- count bottles with certain expiration dates.
The recall is attributable to the presence of an impurity, N-nitrosodiethylamine, that has been classified by the International Agency for Cancer Research as a probable human carcinogen.
According to the posting on the FDA site, NDEA was found in the active pharmaceutical ingredient irbesartan, manufactured by Aurobindo Pharma Limited. The irbesartan tablets are labeled as Westminster Pharmaceuticals and Golden State Medical Supply, Inc. The recalled lots with their expiration dates are listed on the site.
Sciegen Pharmaceuticals said it has not received any reports of adverse events related to this product. Patients are advised to contact their pharmacist or physician for an alternative treatment prior to returning their medication as stopping it could pose a higher health risk.
Sandoz Inc. announced its voluntary recall of one lot of losartan potassium hydrochlorothiazide tablets, also used to treat hypertension, for the same reason on Nov. 8, according to the posting on the FDA website.
The lot being recalled is for 100 milligram/25 milligram tablets in 1,000-count plastic bottles, NDC 0781-5207-10, Lot number JB8912; Exp. Date 06/2020.
The contaminated active ingredient losartan is manufactured by Zhejiang Huahai Pharmaceutical Co. Ltd. Sandoz’s Losartan Potassium Hydrochlorothiazide product is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia.
According to the recall notice, the product was not distributed prior to Oct. 8. Sandoz Inc. said to date it has not received any reports of adverse events related to this lot.
Patients are advised as well to contact their health care provider and to continue to take their medication as the risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any alternative treatment.
FDA informed the public in July that an impurity with the same warning – N-nitrosodimethylamine – had been found in the valsartan active pharmaceutical ingredient manufactured by Zhejiang Huahai and that three companies supplying the U.S. market were recalling some of their products as a result. The recall was expanded to other manufacturers in August.
This spring the European Medicines Agency began reviewing certain angiotensin-II-receptor antagonists – sartans – for both N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA).
The EMA’s initial review initially was focused on valsartan medicines but, according to its website, was expanded as a precautionary measure to include other “sartan” medicines with a similar chemical structure in September following the detection of very low levels of NDEA in some batches of losartan.