499,800 Defective DPT Vaccines Shipped to Children in China
FDA is testing samples of valsartan API and finished products to confirm the amount of impurity of N-nitrosodimethylamine (NDMA)
Chinese State Council investigators have discovered an additional 499,800 defective DPT vaccines produced by Changchun Changsheng Life Sciences Limited, reported Xinhuanet News.
This new total is nearly double the original estimate of 252,600 defective DPT doses.
Approximately 76.2 percent of children who had received the first batch of unqualified DPT vaccines, labeled "201605014-01", were revaccinated.
These children were located in the Shandong and Anhui provinces, located in eastern China.
Additionally, Chinese health and drug authorities have made plans for those subjected to the second batch of vaccines, labeled "201605014-02", to renew their vaccinations.
In October 2017, the DPT vaccine produced by Changchun Changsheng Life Sciences Limited was found to be defective.
The company's DPT vaccine production has since been suspended, and numerous company executives have been arrested.
DPT refers to a combination of vaccines against three infectious diseases: diphtheria, pertussis, and tetanus.
This vaccine scandal erupted after Changchun Changsheng was found forging production data and violating standards in making rabies vaccines.
Previous reporting includes:
- Second Chinese Pharma Included in Valsartan Recall
- Valsartan-Containing Product Recall Expanded by FDA
- Chinese Vaccine Producer Faked Data Since 2014
In the USA, the FDA is working with drug manufacturers to ensure future valsartan active pharmaceutical ingredients are not at risk of N-nitrosodimethylamine (NDMA) in the formation.
NDMA is classified as a probable human cancer-causing substance.
Consumers and healthcare professionals should report any adverse reactions with valsartan-containing products, to the FDA’s MedWatch program to help the agency better understand the scope of the problem.