Drug Safety Alerts

Precision Dose Ranitidine Oral Solution Consumer-Level Recall

11/14/2019

On November 14, 2019, Precision Dose issued a consumer-level recall of Ranitidine Oral Solution 150 mg/10 mL unit dose products manufactured by Amneal and distributed by Precision Dose. 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.

Precision Dose issued this recall in response to the recall issued by the manufacturer (Amneal Pharmaceuticals, LLC), which included affected lots that were repackaged by Precision Dose Inc.

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.

Precision Dose Inc. has not received any reports of adverse events that have been confirmed to be related to this recall. Ranitidine Oral Solution 150 mg/10 mL is a prescription oral product. 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.

Amneal has advised that consumers who have recalled Ranitidine Oral Solution 150 mg/10 mL unit dose productsmanufactured by Amneal 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 recall, please call Precision Dose at 815-624-8523. 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.