When a US drug detected a presumed carcinogen last summer in an IPA acquired to make drugs for high blood pressure, it seemed for the first time to be another problem of contaminated products made in China. Since then, the FDA has learned that the problem is much larger, with two of the largest generic manufacturers now remembering dozens of batches after Mylan discovered a suspected carcinogen in the API that he produced.
Mylan announced last week it discovered that an IPA manufactured in one of its factories in India was contaminated with N-nitrosodiethylamine (NDEA), one of two likely carcinogens monitored by the company. FDA. He recalled 15 batches of valsartan-based products, including seven batches of valsartan tablets, six batches of combined amlodipine and valsartan tablets and two batches of valsartan and hydrochlorothiazide tablets.
This week, Teva Pharmaceuticals announced it was reminding the patient of all batches, 49 in total, of its valsartan-based products in the US, as they had been manufactured with Mylan's API. They include amlodipine and valsartan tablets, as well as amlodipine, valsartan and hydrochlorothiazide tablets.
The global recall of valsartan-based medicines began this summer when the FDA and the EU learned that the valsartan API manufactured by Chinese Zhejiang Huahai Pharmaceuticals contained potential carcinogens, NDEA and N-nitrosodimethylamine (NDMA) . When regulators deepened their research, they learned how certain manufacturing steps taken under certain conditions created minute amounts of impurities, which they were not aware of.
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The FDA has banned APIs from the Huahai manufacturing site in Chuannan. The FDA has criticized the company in a Form 483 to 11 observations to change the manufacturing process without conducting a proper risk assessment.
Since then, the FDA and EU regulators have expanded the investigation to other "sartan" products and found impurities in the irbesartan API produced by Aurobindo, an Indian, and in products to losartan base made from Huahai API.
The FDA states that the risk of impurities is very low and that no adverse effects have been observed. Nevertheless, they continue to require drug manufacturers to withdraw their products from the market when impurities are detected. According to a list (PDF) prepared by the agency, many medications for high blood pressure have not been affected by the recalls.