Amneal Pharmaceuticals of Bridgewater, N.J., is recalling three lots of Nizatidine Oral Solution.
The products may be contaminated with N-Nitrosodimethylamine (NDMA), a probable human carcinogen, above levels established by the FDA.
There are no confirmed reports of adverse events directly related to this recall.
The recalled product is a prescription oral product used for the short-term treatment and maintenance therapy of ulcers and for the treatment of esophagitis and associated heartburn due to gastroesophageal reflux disease
The following product, which was distributed directly to wholesalers who further shipped it to retail pharmacies and consumers nationwide, is being recalled:
|NDC No.||Description||Lot||Expiration Date|
|60846-301-15||Nizatidine Oral Solution||06598004A||04/2020|
|60846-301-15||Nizatidine Oral Solution||06599001A||12/2020|
|60846-301-15||Nizatidine Oral Solution||06599002A||12/2020|
What to do
Customers who purchased the recalled product directly from Amneal should stop using it and contact Inmar at (855) 319-4807, Monday – Friday, 8:00 am – 5:00 pm (EST) or by e-mail at DrugSafety@amneal.com for further information.