Two more blood pressure medications have come under voluntary recall in the last two weeks, according to the US Food and Drug Administration.
The FDA announced on 30 October that ScieGen Pharmaceuticals has voluntarily recalled its irbesartan tablets in 75, 150 and 300 milligram dosage forms packaged in bottles of 30 and 90 counts with certain expiration dates.
The recall is due to the presence of an impurity, N-nitrosodiethylamine, which has been classified by the International Agency for Cancer Research as a probable carcinogen for humans.
According to the placement 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 parties with their due dates are listed on the site.
Sciegen Pharmaceuticals said it has not received any reports of adverse reactions related to this product. Patients are advised to contact their pharmacist or physician for an alternative treatment prior to returning their medication, because stopping may lead to a higher health risk.
Sandoz Inc. announced the voluntary recall of one batch of potassium losartan hydrochlorothiazide tablets, also used for the treatment of hypertension, for the same reason on November 8, according to the publication on the FDA website.
The lot that is recalled is for 100 milligrams / 25 milligram tablets in plastic bottles of 1000 pieces, NDC 0781-5207-10, lot number JB8912; Exp. Date 06/2020.
The contaminated active ingredient losartan is produced by Zhejiang Huahai Pharmaceutical Co. Ltd. The Losartan Potassium Hydroxidothiazide product from Sandoz is manufactured by Lek Pharmaceuticals dd, Ljubljana, Slovenia.
According to the recall notification, the product was not distributed before 8 October. Sandoz Inc. has reported to date that it has not received any reports of side effects related to this fate.
Patients are also advised to contact their healthcare provider and continue to take their medication because the risk of harm to a patient's health may be greater if treatment is stopped immediately without any alternative treatment.
FDA informed the public in July that an impurity with the same warning – N-nitrosodimethylamine – was found in the valsartan active pharmaceutical ingredient manufactured by Zhejiang Huahai and that three companies supplying the US market, recover some of their products as a result. The recall campaign was extended to other manufacturers in August.
This spring, the European Medicines Agency started assessing certain angiotensin II receptor antagonists – sartans – for both N-nitrosodimethylamine (NDMA) and N-nitrosodiethylamine (NDEA).
The original investigation by the EMA was initially focused on valsartan medicines, but according to its website it was extended as a precautionary measure with other "sartan" medicines with a similar chemical structure in September, after the detection of very low levels of NDEA in some batches of losartan.