On Jan. 3, the FDA said Torrent Pharmaceuticals has added eight more lots of losartan potassium tablets to its recall list. Losartan potassium is a drug used to treat high blood pressure and is also used to treat kidney disease in diabetic patients.
The new recall includes 30-, 90- and 1,000-count bottles of 100-milligram tablets; 30-, 90- and 1,000-count bottles of 50-milligram tablets; and 90-count bottles of 25-milligram tablets, according to the FDA.
The “recall is due to trace amounts of N-Nitrosodiethylamine (NDEA) in the losartan active pharmaceutical ingredient,” which was manufactured by Hetero Labs Limited, according to the FDA. NDEA, found in rocket fuel, is classified by experts as a carcinogenic and mutagenic organic compound.
Torrent and Hetero Labs are both based in India.
“Torrent is only recalling lots of losartan medication containing NDEA above the interim acceptable intake level of 0.27 parts per million,” said the FDA.
The agency said that patients taking the recalled medications should keep taking their medicine until their doctor or pharmacist replaces the medications or if the doctor prescribes a different drug.
Aurobindo Valsartan Recalled
Earlier in the week, the FDA announced the recall of certain lots of valsartan, another blood pressure and heart drug, made by Aurobindo Pharma USA.
It said that “two lots of valsartan tablets, 26 lots of amlodipine and valsartan combination tablets, and 52 lots of valsartan and hydrochlorothiazide (HCTZ) combination tablets” are being recalled after NDEA was discovered.
“Aurobindo is recalling lots of valsartan-containing medication that tested positive for NDEA above the interim acceptable daily intake level of 0.083 parts per million,” according to the agency.
A month ago, the FDA provided an update about its ongoing recall of heart and blood pressure medication due to impurities that could cause cancer.
It said Mylan Pharmaceuticals “is expanding its voluntary recall to include all lots of non-expired valsartan-containing products due to trace amounts of N-Nitrosodiethylamine (NDEA) in the valsartan active pharmaceutical ingredient (API) manufactured by” by Mylan Inc. Mylan Pharmaceuticals is based in Pennsylvania.
An additional 104 lots of drugs include 26 lots of amlodipine and valsartan tablets, another 51 lots of valsartan tablets, and 27 lots of valsartan and hydrochlorothiazide tablets, the FDA said.
They were distributed across the United States from March 2017 until November 2018, the agency added.
Warning to Chinese Company
Meanwhile, in December, the FDA issued a warning to Chinese drug manufacturer Zhejiang Huahai Pharmaceutical Co. Ltd. for “several manufacturing violations at ZHP’s Chuannan facility, including impurity control, change control, and cross-contamination from one manufacturing process line to another.”
Zhejiang Huahai Pharmaceutical was also placed “on import alert” by the FDA earlier this year due to impurities in valsartan.