Earlier this month, Mylan Pharmaceuticals announced a recall of three blood pressure medications that were found to contain small amounts of a substance believed to cause cancer. The drugs all include a medication called “valsartan” which has been the subject of an ongoing FDA investigation. Mylan, a generic drug company, recalled three medications it has sold: valsartan tablets, and two other tablets that combine valsartan with amlodipine and hydrochlorothiazide. Mylan’s recall is the latest in a series of recalls that began in July.
On December 11th, the FDA stated in a press release that it had sent a warning letter to the Chinese manufacturer of valsartan, ZHP, informing them that they are subject to an ongoing investigation due to customer complaints from 2016 and June of 2018. The FDA noted in its letter that batches of valsartan from their facility contained an ingredient that is internationally categorized as a probable carcinogen. The FDA went on to state that ZHP has failed to address and resolve these concerns, and thus concluded that the issue reveals “a disturbing lack of oversight” in ZHP’s manufacturing processes.