Company Announcement Date: October 25, 2019
FDA Publish Date: October 25, 2019
Product Type: Drugs
Reason for Announcement: Due to above levels of N-Nitrosodimethylamine (NDMA)
Company Name: Lannett Company, Inc.
Brand Name: Lannett Company, Inc.
Product Description: Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL
Lannett Company, Inc. today announced that it 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 for Ranitidine Hydrochloride Syrup (Ranitidine Oral Solution, USP). Lannett was notified by FDA of the potential presence of NDMA on September 17, 2019 and immediately commenced testing of the Active Pharmaceutical Ingredient (API) and drug product. The analysis confirmed the presence of NDMA.
Risk Statement: 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 and is packaged in bottles of 16 fluid ounces (one pint) (NDC 54838-550-80). The affected Ranitidine Syrup lots include the following:
The product can be identified by NDC number and batch numbers provided above. Ranitidine Syrup was distributed nationwide to wholesalers/distributors.
Lannett is notifying its distributors and customers via email and via the Lannett website, and is arranging for return of all recalled products. Wholesalers and distributors (direct customers of Lannett) that have Ranitidine which is being recalled should contact Lannett customer service for instructions with regard to returning any remaining stock to Lannett.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.