Loading...
By the Editors
Three lots of prescription nizatidine have been recalled after detection of trace amounts of N-nitrosodimethylamine (NDMA), a probable human carcinogen. These are the first nizatidine recalls since concerns over NDMA in antireflux drugs emerged in September 2019.
In related news, several lots of ranitidine are being recalled because of the same impurity, adding to a series of ranitidine recalls over NDMA.
The FDA recently asked manufacturers to test all lots of nizatidine and ranitidine for NDMA before putting them on shelves. Details of the latest recalls are available at the first link below.
Comment
LINK(S):
FDA notices on ranitidine and nizatidine recalls (Free)
Background: Physician's First Watch coverage of FDA's request to manufacturers (Free)
Background: Full Physician's First Watch coverage of NDMA (Free)