Valsartan Recall Expanded, FDA Investigating Products from Outside China | IUK Med Online
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Valsartan Recall Expanded, FDA Investigating Products from Outside China

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Valsartan Recall Expanded, FDA Investigating Products from Outside China

Other ARB manufacturers subject to FDA investigation

MedpageToday

  • by Contributing Writer, MedPage Today

More valsartan products are under recall, according to an announcement from the FDA.

Added to the list of products under recall are valsartan-containing products manufactured by Hetero Labs Limited in India, labeled as Camber Pharmaceuticals in the U.S. However, not all Camber valsartan products distributed in the U.S. are being recalled, the agency noted in an updated statement.

The trouble stems from the discovery of N-nitrosodimethylamine (NDMA) impurities in the recalled Camber products. Hetero Labs makes the active pharmaceutical ingredient for these valsartan products using a process akin to that of Zhejiang Huahai Pharmaceuticals, the Chinese supplier to affected companies in the first round of valsartan recalls announced in mid-July.

NDMA is a probable human carcinogen, according to lab tests.

Hetero Labs tests show their valsartan has too much NDMA, albeit at levels that are generally lower than what was discovered in the active pharmaceutical ingredient manufactured by Zhejiang.

FDA is testing valsartan products for NDMA and working with other manufacturers of valsartan active pharmaceutical ingredient to see if they might be at risk of NDMA formation in their manufacturing processes. Additionally, the agency is investigating whether other angiotensin II receptor blockers are also at risk of NDMA contamination.

Warnings of NDMA impurities in valsartan first emerged in Europe and the United Kingdom in early July.

2018-10-08T00:00:00-0400

last updated

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Medpage Today

Valsartan Recall Expanded, FDA Investigating Products from Outside China

Other ARB manufacturers subject to FDA investigation

MedpageToday

  • by Contributing Writer, MedPage Today

More valsartan products are under recall, according to an announcement from the FDA.

Added to the list of products under recall are valsartan-containing products manufactured by Hetero Labs Limited in India, labeled as Camber Pharmaceuticals in the U.S. However, not all Camber valsartan products distributed in the U.S. are being recalled, the agency noted in an updated statement.

The trouble stems from the discovery of N-nitrosodimethylamine (NDMA) impurities in the recalled Camber products. Hetero Labs makes the active pharmaceutical ingredient for these valsartan products using a process akin to that of Zhejiang Huahai Pharmaceuticals, the Chinese supplier to affected companies in the first round of valsartan recalls announced in mid-July.

NDMA is a probable human carcinogen, according to lab tests.

Hetero Labs tests show their valsartan has too much NDMA, albeit at levels that are generally lower than what was discovered in the active pharmaceutical ingredient manufactured by Zhejiang.

FDA is testing valsartan products for NDMA and working with other manufacturers of valsartan active pharmaceutical ingredient to see if they might be at risk of NDMA formation in their manufacturing processes. Additionally, the agency is investigating whether other angiotensin II receptor blockers are also at risk of NDMA contamination.

Warnings of NDMA impurities in valsartan first emerged in Europe and the United Kingdom in early July.

2018-10-08T00:00:00-0400

last updated

Comments

Accessibility Statement

At MedPage Today, we are committed to ensuring that individuals with disabilities can access all of the content offered by MedPage Today through our website and other properties. If you are having trouble accessing www.medpagetoday.com, MedPageToday's mobile apps, please email legal@ziffdavis.com for assistance. Please put "ADA Inquiry" in the subject line of your email.



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Dr Irfanullah Khan Born: 15th July,1994 in Khagram,Dir Upper KPK Pakistan. Others names:Doctor Irfo,Peshoo Education:Pharm-D Scholar Graduated from Abasyn University Peshawar. Occupation:Clinical Pharmacist,Doctor,Entrepreneur. Home Town:Dir Upper Height: 6 feet. Website:Iukmedonline.com

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