Health Canada has found that a manufacturing site of Chinese drug company Zhejiang Huahai Pharmaceuticals isn’t up to standard, meaning Canadian companies can no longer import its products for use in medications.
Zhejiang Huahai Pharmaceuticals made valsartan, the active ingredient in a group of blood pressure medications that were the subject of several recalls over the summer and early fall.
The valsartan in these medications was found to contain the impurities N-nitrosodiethylamine (NDEA) and N-nitrosodimethylamine (NDMA), which could cause cancer over long-term exposure. These drugs are often prescribed to treat patients with high blood pressure to prevent stroke or heart attacks. They’re also given to patients who have recently had a stroke or heart attack.
Designating the manufacturing site as “non-compliant with requirements for Good Manufacturing Practices” means that Canadian companies cannot import ingredients from that site unless they are medically necessary, according to a press release from Health Canada.
Health Canada defines a medically necessary drug as a drug that is authorized for sale in Canada that is used to prevent, treat or diagnose a serious or life-threatening disease or medical condition for which there is no available alternative. None of the drugs from this particular facility are currently designated medically necessary.
The department is assessing the possible effects of this designation on the drug supply and whether further action needs to be taken. It made its decision based on a recent inspection by the U.S. Food and Drug Administration.
That inspection found problems with quality control, purity testing and inadequate cleaning procedures. “Your manufacturing processes are not always capable of consistently producing final products meeting all product quality control specifications,” wrote the FDA inspectors. They also found that some substances used on machinery, like lubricants and oils, were not always food grade.
All drugs containing valsartan manufactured by Zhejiang Huahai Pharmaceuticals have already been recalled in Canada, Health Canada says, and as such there are no further recalls at this time.
Health Canada is working with other departments in the U.S. and European Union to figure out the root cause of the problem and determine whether such issues can be prevented in the future.
For a full list of valsartan-containing medication that has and has not been recalled, you can visit the Health Canada website.
If you have questions or concerns about your medication, you should consult a health care professional and not make any changes to your medication yourself without medical advice.