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Ulcer and heartburn medication recalled over NDMA concerns

Amneal Pharmaceuticals, LLC has issued a recall of 3 lots of their Nizatidine Oral Solution due to “potential N-Nitrosodimethylamine (NDMA) amounts exceeding the levels established by the FDA.” NDMA, as we’ve written about on this website than more we’d like to, is a probable human carcinogen. A “probable human carcinogen” means it can cause cancer. So needless to say, when you’re taking a prescribed medication, you don’t want to be ingesting something that can lead to cancer.

 

Recalled Products:

NDC Number: 60846-301-15

Lot Number: 06598004A

Expiration Date: 04/2020

 

NDC Number: 60846-301-15

Lot Number: 06599001A

Expiration Date: 12/2020

 

NDC Number: 60846-301-15

Lot Number: 06599002A

Expiration Date: 12/2020

 

According to the recall notice, Nizatidine Oral Solution is prescribed “for the short-term treatment and maintenance therapy of ulcers and for the treatment of esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD).” The recalled solution was manufactured in New Jersey, but distributed to retailers and consumers nationwide. Fortunately, as of the time this story was posted, no illnesses have been reported. Customers should cease use of the recalled solution, and should contact Inmar at 855-319-4807, Monday – Friday, 8:00 am – 5:00 pm, EST for further information.

To read the official Amneal Pharmaceuticals, LLC recall notice on the U.S. Food and Drug Administration's website, click here: https://bit.ly/2VAQS9e