Another medication for treating high blood pressure has been recalled over concerns it could cause cancer for exceeding recommended levels of a potentially cancerous ingredient.
Prinston Pharmaceutical Inc. on Friday issued a voluntary recall of one lot of Irbesartan tablets and seven lots of Irbesartan HCTZ tablets following the results of tests that showed the drugs contain trace amounts of a cancer-causing material.
Irbesartan and Irbesartan HCTZ are drugs used to control high blood pressure and treat heart failure. Here is the list of the affected products.
The drug company said the medications contained unacceptable levels of Nitrosodiethylamine, or NDEA, which is classified as a probable human carcinogen by the International Agency for Research on Cancer.
Prinston Pharmaceutical has so far received no report of adverse events linked to the recall.
API Manufactured By Zhejiang Huahai Pharmaceuticals
The active pharmaceutical ingredient used in the drugs was manufactured by Zhejiang Huahai Pharmaceuticals in China, the company linked to other recalls of prescribed blood pressure drugs Valsartan and Losartan since July.
Huahai has said the impurities are also found in other drug makers' APIs, but the FDA said that the levels found in Huahai's products were higher compared with the others.
In a warning letter the FDA sent to Huahai in late November, the agency said that when the pharmaceutical company altered its manufacturing process in 2011, it did not consider that including a solvent suspected of producing the impurity in the process could lead to the formation of impurities in the APIs.
"Your intention was to improve the manufacturing process, increase product yield, and lower production costs," FDA said in a warning letter to Huahai Executive Vice President Jun Du.
"However, you failed to adequately assess the potential formation of mutagenic impurities when you implemented the new process."
The FDA also said the formation of the impurities could have been found and resolved earlier, but Huahai did not take seriously a complaint from a customer whose testing uncovered one of the carcinogens in the API that Huahai produced.