RECALL: Voluntary recall of Nizatidine ordered
WASHINGTON (KAIT) - A pharmaceutical company has began a voluntary nationwide recall of three lots of Nizatidine capsules, also known as Axid, due to the discovery of a possible human carcinogen, according to the FDA.
The federal agency posted on Twitter that the recall was due to trace amounts of NDMA (N-Nitrosodimethylamine) being found.
FDA officials also said on their website that the products were manufactured by Mylan Pharmaceuticals, distributed nationwide to wholesalers, mail order and retail pharmacies and a distributor between June 2017 and August 2018.
“While Mylan has not received any reports of adverse events related to these batches to date, this product is being voluntarily recalled due to defective trace amounts of an impurity N-nitrosodimethylamine (NDMA) contained in the API Nizatidine, USP, manufactured by Solara Active Pharma Sciences Limited,” officials said.
The FDA asks people to contact their doctor or healthcare provider if they have had any problems with the medicine.
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