The heart medicine, Valsartan, was recently pulled from U.S. pharmacies, as well as those in other countries like Germany, Canada, France, and Sweden.
The Chinese supplier, ZHP, issued a recall notice in July after finding traces of a dangerous carcinogen in substances supplied for the production of Valsartan. China’s Food and Drug Administration said that it screened all Chinese suppliers of the Valsartan ingredients to mitigate further problems.
This incident follows other recent recalls of Chinese-made vaccines for diphtheria and tetanus (DPT) and rabies.
- Valsartan: FDA recalls common heart drug, joins 22 other countries
- FDA recalls blood pressure, heart failure medications due to potential cancer risk
Check out related OM in the News posts about the risk to national security when the supply chain becomes too lean, and several medical supply shortages.
This post is based on the CNN article, Chinese company recalls tainted heart medicine from stores worldwide, by Ben Wescott and Yong Xiong, July 30, 2018; and the YouTube videos, Valsartan: FDA recalls common heart drug, joins 22 other countries, by ABC Action News, July 16, 2018, and FDA recalls blood pressure, heart failure medications due to potential cancer risk, by WXYZ-TV Detroit | Channel 7, July 16, 2018. Image source: Gary S Chapman/Getty Images.
1. How does this recall relate to quality of design and quality of conformance for Chinese goods?
Guidance: At a time when the Chinese government is trying to build global confidence in the quality of its products, international recalls of tainted drug substances are not helping. While it was quick to respond to the Valsartan and other recent vaccine recalls and did alert the Chinese population, it simultaneously removed social media posts about the issue and hastened to minimize the extent of the problem.
Chinese products have long had a reputation for questionable quality and dubious ingredients, even among its own people, which has given rise to a huge grey market of higher quality goods coming in from the Western world via daigou or personal shoppers as well as through legitimate channels. Because of great differences in the enforcement of intellectual property rights and regulations in the supply chain, deficiencies in quality and safety have the potential to rise to much more serious levels than they might in the United States. It may be difficult for the Chinese government to realize its objective of greater respect for the quality of its products if it remains unwilling to crack down on companies that are not operating in what would be considered ethical ways by Western standards.
2. How does this recall relate to matters of supply chain management in the United States?
Guidance: As American businesses source their supplies or ingredients from manufacturers in China, they must weigh the trade-off between lower costs and risks of safety or recall such as what has just been seen with Valsartan. America’s pharmaceutical industry has maintained high standards of safety and in general enjoys a reputation of trust among the American public, but incidents like this may cause companies to reassess their sourcing if public safety is at risk.