The Pendopharm Division of Pharmascience Inc. is recalling two lots of Axid (nizatidine) from the Canadian market, for containing the maximum acceptable limit of a nitrosamine impurity and probable human carcinogen, N-nitrosodimethylamine (NDMA).
Axid is a prescription drug that is used to treat ulcers in the stomach and intestine as well as heartburn. A carcinogen, on the other hand, is any substance capable of causing cancer.
Its recall comes a little more than six months after a considerable amount of ranitidine products were pulled from the marketplace as a precautionary measure due to the presence of NDMA. And five months since the Pendopharm Division of Pharmascience Inc. agreed to stop production of Axid in Canada, after testing detected NDMA in nizatidine.
Health Canada has been working with its international regulatory partners to investigate the presence of NDMA and other nitrosamine impurities found in certain medications since the summer of 2018.
Since that time, it has been determined that NDMA is not expected to cause harm or increase the risk of cancer when ingested at low levels, even if the individual did so every day for 70 years.
Test results have shown that NDMA levels may increase over time in some nizatidine products, however, which is why the following Axid products have been recalled, despite the fact that they do not exceed the maximum limit.
The lots being recalled at this time are as follows:
- Axid Caps 100, DIN: 00778338, 150 mg, Lot: 616927, EXP: Aug 31, 2020
- Axid Caps 100, DIN: 00778338, 150 mg, Lot: 617088, EXP: Aug 31, 2020
Consumers are encouraged to check the lot number on their Axid product or contact their pharmacist to determine whether it is subject to this recall.
Health Canada has advised individuals prescribed nizatidine products, including those recalled, to not stop taking their medication until speaking with their health care provider as the risk of not treating the condition may be greater than that associated with exposure to NDMA.
Those with additional questions may contact the Pendopharm Division of Pharmascience Inc. at 1-888-550-6060 or [email protected].
Find the full product recall here.