Mylan recalls close-to-expiration nizatidine capsules over NDMA impurity
Yesterday, Mylan announced a voluntary recall of three lots of nizatidine capsules due to the detection of trace amounts of N-nitrosodimethylamine (NDMA) contained in the active pharmaceutical ingredient (API), which was manufactured by Solara Active Pharma Sciences.
The lots involved in the recall include nizatidine capsules of 150mg and 300mg strength, which were distributed between June and August 2017. Two lots had an expiration of January 2020, with the additional lot set to expire on May 2020.
Nizatidine is chemically similar to ranitidine, which instigated a wave of recalls mid-way through last year due to the discovery of NDMA at levels deemed unsafe.
The latest medication to be voluntarily recalled is also used for gastrointestinal disorders, including the short-term treatment of active duodenal ulcers and heartburn related to gastroesophageal reflux disease.
The US Food and Drug Administration (FDA) had already warned manufacturers that investigations into nizatidine should be instigated last month.
The agency asked manufacturers of the drug to conduct laboratory testing to examine levels of NDMA and send samples to itself. Further than this, the FDA requested manufacturers expand their testing for NDMA to include all lots of the medication before making them available to consumers.
In provisional studies, the agency noted that nizatidine and ranitidine does not form NDMA in ‘typical stomach conditions’ but stressed that it needed to further investigate how the medicines behaves in the body, with plans to do so.
The most recent recalls are the latest step in an investigation that has been ongoing since summer 2018, when the first discovery was made of valsartan-based medications being contaminated with NDMA.