The FDA issued an initial recall and then later expanded it until over a dozen manufacturers of valsartan were affected, with a few other companies voluntarily issuing their own recall as well. Amneal Pharmaceuticals, LLC is recalling three lots of Nizatidine Oral Solution.

On September 28, the FDA also put this facility on There may be confusion regarding which products are affected by ARB recalls and which are not, especially concerning the most recent U.S. recalls of valsartan-containing products using API manufactured by Mylan that tested positive for unacceptable levels of NDEA, the FDA pointed out. It is a chemical that forms as a byproduct of some industrial processes. And on top of that you want it to be safe, not just [effective],” Beavers says. “So when you have these issues that come up and question the purity and safety of the product, you really do start to question the source it’s coming from and the company you trust.”The GAO calls offshore manufacturing of drugs a “high-risk issue,” one that imposes far-reaching responsibilities and increasing demand on the FDA. The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing. So either way, the patient gets punished for this.”About 40% of finished medications are made overseas, according to the Government Accountability Office, the investigative arm of Congress. The portions of The Legal Examiner Affiliate Network maintained and operated by law firms are Legal Advertising. The problem began in July when the first batch of valsartan blood pressure medications were recalled.

Valsartan is an angiotensin II receptor blocker (ARB) that treats high blood pressure and heart failure. Outsourcing can lead to communication problems between the consumer-facing company and its manufacturer, “and you kind of get what you pay for.” The problems may happen at “a very small percentage” of plants -- but he adds, “Once you lose control of a process, all bets are off.”“You really don’t have control over what’s going on, particularly when you go to low-cost countries like China and India,” says Handfield, who has advised companies involved in earlier drug recalls.

As an example, valsartan/amlodipine/hydrochlorothiazide is one product that has been The FDA asked the public to pay careful attention to the agency’s website for the most accurate and up-to-date information. Recent recall of valsartan is being done in 23 countries because an impurity was found during qualification tests of generic valsartan API manufactured by a Chinese third-party manufacturer. Zhejiang Huahai Pharmaceutical Co. Ltd. was a large manufacturer and supplier for generic valsartan in the United States until the company announced a recall after it found a toxic impurity called N-nitrosodimethylamine (NDMA) in its valsartan in the summer of 2018. In a letter to the company released Wednesday, the FDA outlined several manufacturing violations at ZHP’s Chuannan facility, 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, according to the agency, which is still looking into the root cause of the impurity.“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,” said FDA Commissioner Scott Gottlieb, M.D.

Using this site or communicating with our law firm affiliates through this site does not form an attorney/client relationship. Yet, as the lab tests involved high dosages given to rodents, the exact level of … The risk of cancer from NDMA found in some valsartan is real, and enough to convince the FDA and 21 other nations around the world to take action.