FDA warns API manufacturer involved in valsartan recall

FDA has released a warning letter issued to Zhejiang Huahai Pharmaceutical (ZHP), the manufacturer of the active pharmaceutical ingredient (API) found in valsartan that is the subject of an ongoing FDA investigation into probable cancer-causing impurities in certain commonly prescribed heart medicines.

FDA has released a warning letter issued to Zhejiang Huahai Pharmaceutical (ZHP), the manufacturer of the active pharmaceutical ingredient (API) found in valsartan that is the subject of an ongoing FDA investigation into probable cancer-causing impurities in certain commonly prescribed heart medicines. The letter outlines several manufacturing violations at ZHP’s Chuannan facility in China, including impurity control, change control and cross contamination from one manufacturing process line to another. The warning letter is another step forward in the ongoing investigation. The agency is still looking into the root cause of the impurity. The ZHP facility manufactures API including valsartan, a drug in the angiotensin II receptor blocker (ARB) class used to treat high blood pressure and heart failure. FDA announced recalls of valsartan beginning in July due to the presence of N-Nitrosodimethylamine (NDMA) in API supplied by ZHP. Subsequent international have resulted in additional recalls of valsartan, irbesartan, and losartan-containing products found to contain NDMA and N-Nitrosodiethylamine (NDEA), both known animal and suspected human carcinogens. Patients taking any recalled ARB should continue taking their current medicine until their pharmacist provides a replacement or their doctor provides an alternative treatment option. It also is important to know that not all ARBs contain NDMA or NDEA, so pharmacists may be able to provide a refill of medication not affected by the recall, or doctors may prescribe a different medication that treats the same condition.