Chinese Rabies Vaccine Recall Expands With DPT and Heart Medicine Alert from FDA

Changsheng Biotechnology, Zhejiang Huaihai Pharmaceutical and Wuhan Institute of Biological Products identified in vaccine and medicine recalls
the great chinese wall
(Precision Vaccinations)

The human rabies vaccine manufacturing warning in China may now include recalls of diphtheria, pertussis, and tetanus (DPT) vaccines and various heart medications.

Last week, on July 17th, Chinese regulators ordered Changsheng Biotechnology Co Ltd., to halt production and recall all its rabies vaccines.

According to Reuters, on July 19, 2018, Changsheng Biotechnology told the stock exchange authorities it was being fined related to production concerns uncovered in 2017 of a DPT vaccine.

Reuters reported that the defective DPT vaccine might not confer immunity, but would not affect human safety, provincial authorities had said in November 2017.

Reuters' telephone calls on July 22nd to Changsheng's headquarters went unanswered.

Additionally, Reuters reported Chinese authorities are implicating another company, Wuhan Institute of Biological Products Co. Ltd, in substandard DPT vaccine production.

Separately, according to South China Morning Post,  Zhejiang Huaihai Pharmaceutical said on July 18th, it was recalling a heart drug sold in the United States after the European Medicines Agency found it tainted with an impurity linked to cancer.

Zhejiang Huahai Pharmaceutical is a major supplier of the active ingredient valsartan that it uses to make a generic drug to treat high blood pressure and heart failure.

European regulators said the problem likely dates to changes in manufacturing processes at Zhejiang Huahai in 2012, suggesting that many patients could potentially have been exposed to cancer risk. 

Zhejiang Huahai voluntarily suspended its supplies in the international market after detecting the impurity, N-nitrosodimethylamine (NDMA), in the valsartan product. 

NDMA is classified as a probable human cancer-causing substance. 

In response to this Zhejiang Huahai announcement, on July 17th, the U.S. Food and Drug Administration (FDA) alerted healthcare professionals and patients of a voluntary recall of several drug products containing the active ingredient valsartan.

The FDA said because valsartan is used in medicines to treat serious medical conditions, patients taking the recalled valsartan-containing medicines should continue taking their medicine until they have a replacement product.

“Brookshire Grocery Company has taken the necessary steps to ensure that the affected products are not currently being dispensed,” assured Jeremy H. Ashley, PharmD Clinical Pharmacist, Pharmacy Corporate Development Brookshire Grocery Company.

“Pharmacy Partners are working to contact their patients who potentially could have received the recalled medication. Affected patients are encouraged to consult their physician regarding alternative hypertension treatment before stopping the medication,” said Ashley.

The companies listed are recalling all lots of non-expired products that contain the ingredient valsartan supplied to them by Zhejiang Huahai Pharmaceuticals, Linhai, China.

Zhejiang Huahai has stopped distributing its valsartan API and the FDA is working with the affected companies to reduce or eliminate the valsartan API impurity from future products.

“We’ve found that the valsartan sold by these specific companies does not meet our safety standards. This is why we’ve asked these companies to take immediate action to protect patients,” said Janet Woodcock, M.D., director of the FDA’s Center for Drug Evaluation and Research.

Reuters reporting by Dominique Patton; Additional reporting by Zhou Jianfeng; Editing by Clarence Fernandez.

WAO editor: Gui Qiang  

SCMP reporting by Zhuang Pinghui