Health Canada has announced a ban on all imports from Zhejiang Huahai Pharmaceuticals, the Chinese manufacturer behind a massive worldwide recall for contaminated valsartan.
The Canadian ban was announced on October 2nd, and followed a recent U.S. Food & Drug Administration (FDA) inspection that deemed the company “non-compliant with requirements for Good Manufacturing Practices.”
Pharmaceutical ingredients manufactured by Zhejiang Huahai will only be permitted to enter Canada when they are deemed “medically necessary,” provided that their safety is ensured through additional testing or other means.
Health Canada has not yet identified any products from Zhejiang Huahai that would be considered medically necessary.
Valsartan is the active ingredient in numerous medications used to treat high blood pressure and heart failure. Zhejiang Huahai Pharmaceuticals supplies the ingredient to generic drug manufacturers around the world, including many in the United States and Canada.
In June, the company disclosed that N-nitrosodimethylamine, or NDMA, had been detected in valsartan manufactured at its Zinhai, China facility. Records that the contamination problem may have begun in 2014, when the company altered its production methods.
The U.S. Environmental Protection Agency considers NDMA a probable human carcinogen. It has also been linked to kidney problems and liver damage.
Numerous generic drug makers in the United States, Canada, and Europe have since announced valsartan recalls.
“FDA scientists estimate that if 8,000 people took the highest valsartan dose (320 mg) from the recalled batches daily for the full four years, there may be one additional case of cancer over the lifetimes of these 8,000 people,” the FDA stated in a recall notification published in July. “This assessment led to FDA’s decision to have these batches recalled.”
The FDA issued an import alert for Zhejiang Huahai Pharmaceuticals on September 28th, preventing any of the company’s pharmaceutical ingredients or finished drug products from entering the United States. That same day, regulators in Europe revoked Zhejiang Huahai’s authorization to manufacture valsartan for the European market.
FDA inspectors arrived at the company’s Linhai, China manufacturing plant on July 23rd, and concluded their visit on August 3rd.
“Your manufacturing processes are not always capable of consistently producing final products meeting all product quality control specifications,” the FDA inspection report states.
The FDA’s import alert for Zhejiang Huahai will remain in place until the company improves its quality control systems and determines how its valsartan became contaminated with NDMA.
Patients can also ask their pharmacy if any of their heart or blood pressure drugs have been recalled.
Finally, the FDA has established a dedicated hotline (855-543-3784) to answer consumers’ questions regarding the valsartan recall.