Mylan snared in carcinogen scare with voluntary nizatidine recall
Following a global withdrawal of both generic statins and heartburn med Zantac, a spotlight has been trained on manufacturing that resulted in carcinogen-tainted drugs. Now, months after the Zantac scare, Mylan is the latest drugmaker forced to backtrack distribution of a popular generic.
Mylan will recall three U.S. lots of nizatidine, USP, capsules after trace amounts of a probable carcinogen, N-Nitrosodimethylamine (NDMA), were found in the active pharmaceutical ingredient (API) in tested batches, the company said. The drug's API was produced by India-based drugmaker Solara Active Pharma Sciences.
Mylan's tainted batches of generic nizatidine, approved as a short-term treatment for duodenal ulcers, were distributed through June 2017 and August 2018, and no adverse events have been reported so far, the drugmaker said.The nizatidine recall comes months after positive NDMA testing triggered waves of global recalls and distribution halts for popular heartburn med Zantac (ranitidine).
RELATED: Lab finds NDMA in Zantac can develop during storage
In September, the FDA reported traces amounts of the contaminant had been found in both branded and generic versions of the drug, triggering a series of recalls that lasted weeks. In an attempt to tamp down fears, the FDA clarified its findings in November, saying the amount of NDMA found in those drugs was equivalent to that found in "grilled or smoked meats."
Last week, California-based Emery Pharma reported that NDMA could form after exposure to high heat during storage, potentially providing a clue as to how the probable carcinogen made its way into globally distributed APIs. After the finding, the lab requested the FDA suspend all sales and manufacturing of the drug.
But Zantac wasn't the first instance in which an NDMA scare put the brakes on a globally manufactured drug. In 2018, the FDA issued a mandatory recall of certain "sartan"-based heart pressure meds after a suite of probable carcinogens were found in the drugs' API.
The first global recall included all non-expired generic valsartan sold by Major Pharmaceuticals, Teva and Huahai’s U.S. subsidiary, Solco Healthcare, as well as valsartan/hydrochlorothiazide made by Teva and Solco.
The recall later expanded to other sartan products as impurities turned up in the irbesartan API produced by India’s Aurobindo and in losartan products made using an API from China’s Zhejiang Huahai Pharmaceuticals.
In April, the FDA identified 40 products that it deemed safe for use in an attempt to instill confidence back into the market.