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Amneal recalls Nizatidine Oral Solution

The medication may be contaminated with a probable cancer-causer

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Photo source: FDA
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.DescriptionLotExpiration Date
60846-301-15Nizatidine Oral Solution06598004A04/2020
60846-301-15Nizatidine Oral Solution06599001A12/2020
60846-301-15Nizatidine Oral Solution06599002A12/2020

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.

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