Drug Safety Alerts

American Health Packaging Ranitidine 150 mg Tablets Consumer-Level Recall

11/20/2019

On November 20, 2019, American Health Packaging issued a consumer-level recall of Ranitidine 150 mg tablets manufactured by Amneal Pharmaceuticals and distributed by American Health Packaging. 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.

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.

Ranitidine is a histamine-2 blocker, which decreases the amount of acid created by the stomach.  Prescription ranitidine is approved for multiple indications, including short-term treatment for active duodenal ulcers, treatment pathological hypersecretory conditions, short-term treatment of active, benign gastric ulcers, maintenance therapy for gastric ulcers, treatment of GERD and treatment of endoscopically diagnosed erosive esophagitis.

Amneal has advised that consumers who have recalled Ranitidine 150 mg tablets manufactured by Amneal Pharmaceuticals and distributed by American Health Packaging should stop using the products. Consumers have been advised to call their healthcare provider right away for advice if they may be using affected product or if they do not know if they used affected product.

A list of products and lot numbers affected by this recall are provided here.

CVS Caremark Response:

Please note: These products are not carried by the CVS Caremark Mail Service Pharmacies.

For more information about the consumer-level recall, please call American Health Packaging at 1-800-707-4621. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.