USA – More drugmakers recall nizatidine, ranitidine products over cancer risk

The series of recalls of ranitidine (also known as Zantac) and nizatidine products grew longer with three US Food and Drug Administration (FDA) announcements on Tuesday and Wednesday.

The 150 mg and 300 mg versions of the stomach acid treatment from New Jersey-based generic drugmaker Appco Pharma are being recalled. In addition, Denton Pharma and Northwind Pharmaceuticals also recalled all unexpired lots of ranitidine tablets, 150 mg and 300mg versions. Mylan on Wednesday also recalled three lots of the ulcer treatment nizatidine (including the 150mg and 300mg strengths).

All of the recalls are due to higher-than-acceptable levels of N-nitrosodimethylamine (NDMA), which is classified as a probable human carcinogen. To date, Appco has not received any adverse event reports related to use of the product. Northwind said in its recall that it has ceased distribution of its ranitidine products in the US while the manufacturer continues its efforts to test and investigate in cooperation with the FDA…