Mylan recalls contaminated ulcer drugs

Jan. 9, 2020

Mylan Pharmaceuticals is voluntarily recalling three lots of its ulcer medication for trace amounts of a potential carcinogen.

The three batches of 150 mg and 300 mg Nizatidine capsules being recalled contain a trace amount of the human carcinogen, N-nitrosodimethylamine (NDMA). The NDMA was found in the API, manufactured by Solara Active Pharma Sciences.

Nizatidine is used to treat active duodenal ulcers and active benign gastric ulcers. The recalled batches were distributed nationwide to wholesalers, mail order pharmacies, retail pharmacies, and a distributor between June 2017 and August 2018.

Read the company announcement