Drug Safety Alerts

Ranitidine 150 mg tablets and Ranitidine 300 mg tablets manufactured by Amneal Consumer-Level Recall

11/08/2019

On November 8, 2019, Amneal issued a consumer-level recall of Ranitidine 150 mg tablets and Ranitidine 300 mg tablets. This recall was issued because of potential N-nitrosodimethylamine (NDMA) amounts above levels established by the FDA. 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.

This could be a health hazard or safety risk to patients who may be using product affected by this recall.

A list of the affected products and lot numbers is provided here:

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.

Amneal Pharmaceuticals, LLC. has not received any reports of adverse events that have been confirmed to be directly related to this recall. Ranitidine Tablets manufactured by Amneal are prescription oral products.  Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach.  Prescription ranitidine is approved for multiple indications, including treatment and prevention of ulcers of the stomach and intestines and treatment of gastroesophageal reflux disease. 

CVS Caremark Response: Because of this action, CVS Caremark is sending letters to members who received this product through CVS Caremark Mail Service Pharmacy and their physicians.

Please note: The initial press release issued by Amneal on November 11, 2019 showed 3 impacted NDCs not included on the recall notice issued by Amneal on November 14, 2019. These products (with the explanation for the omission on the November 14, 2019 notice) include:

• Ranitidine Tablets 300mg 1000 count NDC # 65162-0254-11 – There are no unexpired product in the market so it was not included on the recall notice issued on November 14, 2019.
• Ranitidine Tablets 150mg 500 count NDC # 53746-0253-05 – There are no unexpired product in the market so it was not included on the recall notice issued on November 14, 2019.
• Ranitidine Syrup 15mg/mL 16fl. Oz NDC # 65162-0664-90 – This NDC was not released into the market. The product was sold to a repackager to be distributed under a different NDC so it was not included on the recall notice issued on November 14, 2019.

For more information about this recall, please contact Amneal Drug Safety at 1-877-835-5472, Monday through Friday, 8:00 am to 6:00 pm (ET) or visit investors.amneal.com

You may also contact the United States Food and Drug Administration (FDA) toll-free at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit

www.fda.gov.