Lannett Company, Inc. Recalls Ranitidine Syrup

Date: 10/25/19

On October 25, 2019, the U.S. Food and Drug Administration (FDA) announced that Lannett Company, Inc. was recalling Ranitidine Syrup to the consumer level due to the products containing N-Nitrosodimethylamine (NDMA).

The FDA press release states the following:

Lannett Company, Inc. is voluntarily recalling all lots, within expiry, of Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL to the consumer level due to levels of N-Nitrosodimethylamine (NDMA) above the levels recently established by the FDA. NDMA is classified as a probable human carcinogen, a substance that can cause cancer, based on laboratory testing. NDMA is also a known environmental contaminant found in water and foods, including meats, dairy and vegetables.

The product is used as a short-term treatment for active duodenal ulcers, maintenance therapy for duodenal ulcer patients, treatment of 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.

Please immediately check your medical supplies, quarantine any drug products impacted and do not administer them. The identifying NDC number associated with Lannett’s recalled products is as follows: Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL, packaged in bottles of 16 fluid ounces (one pint) (NDC 54838-0550-80).

Review the FDA’s Full Press Release

For questions or concerns, please reach out to Envolve Pharmacy Solutions’ Pharmacy Department by calling 1-800-782-2221.