Another ulcer and heartburn drug is recalled for possibly too much of a carcinogen
Two weeks after the FDA requested all ranitidine (brand name: Zantac) get pulled from the shelves for an NDMA problem, Amneal Pharmaceuticals is recalling three lots of ulcer and heartburn drug Nizatidine for a similar reason.
The amount of NDMA (N-Nitrosodimethylamine), classified as “a probable human carcinogen, in Nizatidine Oral Solution, 15 mg/ml might exceed the FDA’s safe levels. The Amneal-written, FDA-posted recall notice says the company hasn’t heard of any “adverse events that have been confirmed to be directly related to this recall.”
Lot Nos. 06598004A, expiration date 04/2020; 06599001A, expiration 12/2020; and 06599002A, expiration 12/2020 all have NDC No. 60846-301-15. People with these lots should stop using it and call Inmar, which is handling the recall, at 855-319-4807, Monday through Friday, 8 a.m. to 6 p.m., Eastern time. You can also email DrugSafety@amneal.com.
To report problems with the drug, use the above email address; call Amneal at 877-835-5472, Monday through Friday, 8 a.m. to 6 p.m., Eastern time. And report it to the FDA.
