Company Announcement Date: October 25, 2019
FDA Publish Date: October 25, 2019
Product Type: Drugs
Reason for Announcement: May contain N-Nitrosodimethylamine (NDMA)
Company Name: Novitium Pharma
Brand Name: Novitium Pharma
Product Description: Ranitidine Hydrochloride Capsules 150 mg and 300 mg
Novitium Pharma LLC (Novitium) is voluntarily recalling all quantities and lots, within expiry, of Ranitidine Hydrochloride Capsules in the US to the consumer level. Ranitidine Hydrochloride Capsules are being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. To date, Novitium has not received any reports of adverse events related to use of the product as part of this recall.
Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.