Novitium Pharma Issues Voluntary National Recall of Ranitidine Hydrochloride Capsules 150mg and 300mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)

Article

Health Safety and Recalls

Nutrition & Dietetics

Contributed byKrish Tangella MD, MBAMar 01, 2020

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.

On the Article

Approved by

Krish Tangella MD, MBA

Pathology, Medical Editorial Board, DoveMed Team

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