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On Sept. 28, 2018, the Food and Drug Administration (FDA) issued an import alert on all active ingredients and finished drug products from the Zhejiang Huahai Pharmaceuticals factory in Linhau, China, banning them from entering the U.S. This decision was necessary due to a number of serious problems found during FDA inspections of the company's facility.[1]
The most recent inspection, which ultimately prompted the ban, took place in late July to early August 2018.[2] During its...
On Sept. 28, 2018, the Food and Drug Administration (FDA) issued an import alert on all active ingredients and finished drug products from the Zhejiang Huahai Pharmaceuticals factory in Linhau, China, banning them from entering the U.S. This decision was necessary due to a number of serious problems found during FDA inspections of the company's facility.[1]
The most recent inspection, which ultimately prompted the ban, took place in late July to early August 2018.[2] During its inspection, the FDA identified major deficiencies with overall management of and changes to the company's quality control system.[3]
In September, the European Medicines Agency (EMA) announced that a European Union inspection found fault with the way the company investigated impurities in its products.[4]
Two prior FDA inspections, conducted in November 2016 and May 2017,[5] indicated problems with the manufacturer's processes, including a failure to follow procedures to prevent contamination and to ensure product quality.
In July 2018, before the most recent FDA inspection, the FDA and EMA had recalled all products containing the active ingredient valsartan — an angiotensin II receptor blocker used to treat hypertension and heart failure — that was manufactured by Zhejiang Huahai Pharmaceuticals. This was due to the presence of N-nitrosodimethylamine, a known carcinogen, in the valsartan that the company had produced.[6] The August inspection determined that the contamination was most likely caused by changes in the company's process for manufacturing the drug.[7]
After the recalls were announced, the FDA and EMA reported that another carcinogen, N-nitrosodiethylamine, was found in the valsartan produced by this manufacturer.[8]
The FDA has stated that the ban on imports would continue until Zhejiang Huahai Pharmaceuticals determined exactly how the contamination occurred and improved its manufacturing processes to prevent future contamination.[9]
If you are currently taking valsartan, discuss with your doctor whether you should switch to an alternative drug. Not all valsartan products are affected by the recall or the import alert; untainted valsartan products can be obtained from other manufacturers. The FDA maintains a list of recalled valsartan products on its website: https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf.[10]
References
[1] Brooks M. FDA freezes imports from Chinese maker of tainted valsartan. Medscape. September 28, 2018. https://www.medscape.com/viewarticle/902712. Accessed November 14, 2018.
[2] Palmer E. FDA berates Chinese drugmaker tied to global valsartan. FiercePharma. September 21, 2018. https://www.fiercepharma.com/manufacturing/fda-berates-chinese-drugmaker-tied-to-global-valsartan-recall. Accessed November 14, 2018.
[3] Food and Drug Administration. Form FDA 483, Inspectional Observations for Zhejiang Huahai Pharmaceuticals Linhai factory inspection. August 3, 2018. https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/CDERFOIAElectronicReadingRoom/UCM621162.pdf. Accessed November 14, 2018.
[4] Brooks M. FDA freezes imports from Chinese maker of tainted valsartan. Medscape. September 28, 2018. https://www.medscape.com/viewarticle/902712. Accessed November 14, 2018.
[5] Silverman E. FDA found problems at Chinese ingredients maker nearly two years before valsartan recalls. Stat. August 10, 2018. https://www.statnews.com/pharmalot/2018/08/10/fda-valsaran/. Accessed November 14, 2018.
[6] FDA announces recalls of certain valsartan-containing medications because of cancer-causing contaminant. Worst Pills, Best Pills News. October 2018. /newsletters/view/1225. Accessed November 14, 2018.
[7] Palmer E. FDA berates Chinese drugmaker tied to global valsartan. FiercePharma. September 21, 2018. https://www.fiercepharma.com/manufacturing/fda-berates-chinese-drugmaker-tied-to-global-valsartan-recall. Accessed November 14, 2018.
[8] Pharmaceutical Technology. EMA and FDA find additional impurity in valsartan products. September 17, 2018. https://www.pharmaceutical-technology.com/news/impurity-in-valsartan-products/. Accessed November 14, 2018.
[9] Brooks M. FDA freezes imports from Chinese maker of tainted valsartan. Medscape. September 28, 2018. https://www.medscape.com/viewarticle/902712. Accessed November 14, 2018.
[10] U.S. Food and Drug Administration. FDA updates on angiotensin II receptor blocker (ARB) recalls. November 9, 2018. https://www.fda.gov/Drugs/DrugSafety/ucm613916.htm. Accessed November 13, 2018.
