FDA Expands Valsartan Products Recall

The FDA has expanded its recall of products containing valsartan, which is used in medications to treat high blood pressure and heart failure. The agency also has revised information regarding A-S Medication Solutions on the list of recalled products.¹

The products being recalled contain an impurity, N-nitrosodimethylamine (NDMA) in the active pharmaceutical ingredient (API) valsartan manufactured by Zhejiang Huahai Pharmaceuticals of Linhai, China.² NDMA is classified as a probable human carcinogen.²

Some companies are recalling all lots of unexpired products that contain the ingredient valsartan supplied by a third party. Not all valsartan-containing medicines distributed in the United States have valsartan API supplied by Zhejiang Huahai Pharmaceuticals.^2,3 The supplier has stopped distributing its valsartan API.³

Read about the additional impurity found in some recalled products containing valsartan.

The recalled products include Valsartan, Actavis; Valsartan, A-S Medication Solutions LLC; Valsartan, Bryant Ranch Prepack Inc.; Valsartan, Northwind Pharmaceuticals.Valsartan, Prinston Pharmaceuticals’ Solco Healthcare; and Valsartan, Teva Pharmaceuticals’ Major Pharmaceuticals.⁴

Also recalled are Valsartan/Hydrochlorothiazide (HCTZ), Actavis; Valsartan/Hydrochlorothiazide (HCTZ), AvKARE; Valsartan/Hydrochlorothiazide (HCTZ), A-S Medication Solutions LLC; Valsartan/Hydrochlorothiazide (HCTZ), Northwind Pharmaceuticals; Valsartan/Hydrochlorothiazide (HCTZ), Prinston Pharmaceuticals’ Solco Healthcare; Valsartan/Hydrochlorothiazide (HCTZ), Proficient Rx LP; and Valsartan/Hydrochlorothiazide (HCTZ), Remedy Repack.⁴

A-S Medication Solutions is a repackager that used NDC for valsartan products made by Prinston Pharmaceuticals and Teva Pharmaceuticals, labeled as Solco Healthcare and Actavis, respectively, according to the FDA.

Lot numbers of all the recalled products can be found on the FDA's website.

The FDA is working with drug manufacturers to ensure that future valsartan APIs are not at risk of NDMA formation.

FDA Commissioner Scott Gottlieb, MD, said in a statement that the agency is committed to efficacy and safety.²

“When we identify lapses in the quality of drugs and problems with their manufacturing that have the potential to create risks to patients, we’re committed to taking swift action to alert the public and help facilitate the removal of the products from the market,” he said.² “As we seek the removal of certain drug products, our drug shortages team is also working hard to ensure patients’ therapeutic needs are met in the United States with an adequate supply of unaffected medications.”

In addition to its list of recalled products, the FDA is maintaining a list of other products containing valsartan that are not being recalled. Among the non-recalled items are Alembic products including its Valsartan, which is produced internally and does not contain outsourced ingredients, according to the company.⁵

References

• FDA. FDA updates recalled valsartan-containing product information and reminds API manufacturers to evaluate processes for unsafe impurities. www.fda.gov/drugs/drugsafety/ucm613916.htm. Published August 2, 2018. Accessed August 8, 2018.
• FDA announces voluntary recall of several medicines containing valsartan following detection of an impurity [news release]. Silver Spring, MD; July 13, 2018. FDA website. www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm61353htm. Accessed August 8, 2018.
• Voluntary recall of several medicines containing valsartan following impurity detection. Pharmacy Times. pharmacytimes.com/news/voluntary-recall-of-several-medicines-containing-valsartan-following-impurity-detection-. Published July 15, 2018. Accessed August 8, 2018.
• FDA. Products subject to the valsartan recall - updated August 2, 2018. www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf. Accessed August 8, 2018.
• Alembic: Valsartan products not subject to recall. Pharmacy Times. pharmacytimes.com/news/alembics-valsartancontaining-products-not-subject-to-fda-recall-. Published July 31, 2018. Accessed August 8, 2018.