FDA News

FDA issues warning letter to valsartan manufacturer for impurities

The FDA has issued a warning letter to Zhejiang Huahai Pharmaceutical Co. Ltd. detailing violations at its facility that manufactures the active ingredient in valsartan, which is used to treat patients with high BP and HF.

The active ingredient in valsartan is currently being investigated by the FDA for impurities that potentially cause cancer. Violations regarding the company’s production of valsartan include change control, impurity control and cross-contamination from one manufacturing process line to another, according to a press release from the FDA.

As Cardiology Today previously reported, recalls related to products with the active ingredient valsartan were initiated in July and have continued. The recalls were originally due to the impurity N-nitrosodimethylamine and was later expanded to include products containing the impurity N-nitrosodiethylamine.

“We’re continuing to investigate and take action to protect patient health and safety from products in this angiotensin II receptor blocker class that have been found to have dangerous impurities,” FDA Commissioner Scott Gottlieb, MD, said in a press release. “As part of that investigation, we’ve uncovered serious manufacturing violations at ZHP, which is one of the manufacturing facilities that has been linked to these products. The issues cited in the warning letter are associated with the nitrosamine impurities found in these drugs, and these violations reveal a disturbing lack of oversight at this [active pharmaceutical ingredient] manufacturer that puts patients at risk.”

In September of this year, the FDA implemented an import alert on ZHP, alerting the company to halt all active pharmaceutical ingredient production and to stop all products made with the ingredient from entering the U.S.

Patients who are currently taking any angiotensin II receptor antagonists affected by the recall should continue doing so until their doctor provides another treatment option or their pharmacist provides a replacement without the active pharmaceutical ingredient in question, according to the release.

Disclosure: Gottlieb is commissioner of the FDA.

The FDA has issued a warning letter to Zhejiang Huahai Pharmaceutical Co. Ltd. detailing violations at its facility that manufactures the active ingredient in valsartan, which is used to treat patients with high BP and HF.

The active ingredient in valsartan is currently being investigated by the FDA for impurities that potentially cause cancer. Violations regarding the company’s production of valsartan include change control, impurity control and cross-contamination from one manufacturing process line to another, according to a press release from the FDA.

As Cardiology Today previously reported, recalls related to products with the active ingredient valsartan were initiated in July and have continued. The recalls were originally due to the impurity N-nitrosodimethylamine and was later expanded to include products containing the impurity N-nitrosodiethylamine.

“We’re continuing to investigate and take action to protect patient health and safety from products in this angiotensin II receptor blocker class that have been found to have dangerous impurities,” FDA Commissioner Scott Gottlieb, MD, said in a press release. “As part of that investigation, we’ve uncovered serious manufacturing violations at ZHP, which is one of the manufacturing facilities that has been linked to these products. The issues cited in the warning letter are associated with the nitrosamine impurities found in these drugs, and these violations reveal a disturbing lack of oversight at this [active pharmaceutical ingredient] manufacturer that puts patients at risk.”

In September of this year, the FDA implemented an import alert on ZHP, alerting the company to halt all active pharmaceutical ingredient production and to stop all products made with the ingredient from entering the U.S.

Patients who are currently taking any angiotensin II receptor antagonists affected by the recall should continue doing so until their doctor provides another treatment option or their pharmacist provides a replacement without the active pharmaceutical ingredient in question, according to the release.

Disclosure: Gottlieb is commissioner of the FDA.