Another Chinese product using potentially substandard ingredients has slipped through the regulatory cracks into the U.S.
Westminster Pharmaceuticals is recalling all lots of its thyroid drugs levothyroxine and liothyronine in five dose forms because they were made with an API from China’s Sichuan Friendly Pharmaceutical.
The FDA banned all products made by Sichuan Friendly in March after an inspection found big problems at the manufacturing plant of the Chinese company. Westminster in its voluntary recall said its had used the API to make the thyroid medication before the FDA had put the ban in place. It said no adverse reactions have been reported from the drugs, but it is recalling them because they are used in the treatment of serious medical conditions
The FDA issued a warning letter to the plant in June after an inspection last year found problems at the company’s plant at Neijiang, Sichuan. Inspectors found the plant had no data to support the shelf life labeled on the company's APIs. They also said the Sichuan Friendly facility did not test for residual solvent levels in its intermediate or finished API batches to determine whether results fell within acceptable levels.
The recall comes amid another global recall of products made with the API valsartan from a Chinese drugmaker. Zhejiang Huahai Pharmaceutical set off a global recall after it informed global regulators last month that it had discovered the suspected cancer-causing impurity N-nitrosodimethylamine in its valsartan API after changing its manufacturing pr0ocess. The FDA recently said it investigation found the tainted products may have been on the market for as long as four years.
The FDA actually inspected the Huahai plant in 2016 and again last year. Form 483s indicate the plant had little regard for quality control and blamed out-of-specification test results on “ghost peaks,” lab errors and environmental pollution.
It repeatedly reanalyzed API batches to achieve passing results, even when tests showed a “large differential,” then shipped them to the U.S. without ever investigating why the out-of-spec results occurred in the first place.