(RxWiki News) Additional ranitidine products are being recalled because they might contain a cancer-causing impurity.
In late September, the US Food and Drug Administration (FDA) issued a statement about low levels of a possible cancer-causing impurity found in some ranitidine products. These may be found under the brand name Zantac. These drugs are available over the counter (OTC) and via prescription.
Now, Novitium Pharma LLC is voluntarily recalling all quantities and lots of its prescription ranitidine capsules (150 mg and 300 mg). The company stated that it had not received any notice of adverse events tied to these products.
Furthermore, Lannett Company, Inc., is voluntarily recalling 45 lots of ranitidine syrup (15mg/mL).
In the case of these newest recalls, the recalled medications are available by prescription only. The prescription version of ranitidine is used to treat and manage ulcers of the stomach; it also treats gastroesophageal reflux disease (GERD).
The possible cancer-causing impurity (a nitrosamine impurity) the FDA found in ranitidine products is called N-nitrosodimethylamine (NDMA).
The FDA said consumers should refer to the details and recall instructions provided by the companies.
If you experience any problem that may be related to taking recalled ranitidine, speak with your health care provider. The FDA also encouraged people to report any side effects tied to ranitidine to the FDA MedWatch program.
If you have any questions or concerns, speak with your health care provider.
Written by Anyssa Garza, PharmD, BCMAS