Zhejiang Huahai Pharmaceuticals, the Chinese manufacturer behind recent valsartan recalls, has been banned from importing pharmaceutical ingredients into the United States.
The U.S. Food & Drug Administration (FDA) issued an import alert on Friday, September 28th, after an inspection of the company’s manufacturing facility in Linhai, China revealed numerous issues, including problems with its quality control systems and its handling of products with impurities.
The FDA’s counterpart in Europe – the European Medicines Agency – also announced on Friday that Zhejiang Huahai had not complied with good manufacturing processes. It’s Linhai factory is no longer authorized to manufacture valsartan for the European market.
Zhejiang Huahai produces about 50 different active pharmaceutical ingredients (API), including the active ingredient in valsartan, a medication used to treat high blood pressure and heart failure.
In June, the company informed its customers that N-nitrosodimethylamine, or NDMA, had been detected in the active ingredient used to manufacture valsartan. NDMA is designated a probable human carcinogen by the U.S. Environmental Protection Agency. It has also been linked to liver damage and reduced kidney function.
Since then, more than 2,300 batches of valsartan have been recalled by generic drug makers in the United States and 21 other countries.
Earlier this month, the FDA reported that a second potentially cancer-causing contaminant N-Nitrosodiethylamine, or NDEA, had been detected in three valsartan batches marketed by Torrent Pharmaceuticals. The affected batches were included in a valsartan recall previously announced by the company.
NDMA is an organic compound that sometimes occurs as a byproduct of the manufacturing process. The FDA has suggested that NDMA-contaminated valsartan may have resulted from a change in production methods that Zhejiang Huahai instituted in December 2012.
Many of the deficiencies cited by the FDA during its recent inspection were related to that process change. Among other things, the agency faulted Zhejiang Huahai for failing to perform enough investigations or provide adequate documentation for the changes.
The FDA’s import alert prevents any API or finished drug products manufactured by Zhejiang Huahai from legally entering the United States. The ban will remain in place until the company determines how the contamination occurred and improves its quality control systems.
According to the FDA, if 8,000 people took the highest valsartan dose (320 mg) from the recalled batches daily in the 4 years since Zhejiang Huahai altered its production process, there could be one additional case of cancer over the lifetimes of these 8,000 people.
The FDA has warned patients not to stop taking their valsartan, as doing so could have serious health consequences. Those who have valsartan drugs included in the recalls should contact their health care provider for a medication switch.
The agency has posted lists of products included in the valsartan recall, as well as those not included in the recall. Patients can also contact their pharmacy for additional help in determining whether their valsartan has been recalled, or they can call FDA’s dedicated hotline at 855-543-3784. which is being manned by a group of pharmacists and nurses.