Drug Safety Alerts

Ranitidine Syrup Consumer-Level Recall

10/25/2019

On October 25, 2019, the United States Food and Drug Administration (FDA) issued notice regarding a consumer-level recall of Ranitidine Syrup 15mg/mL NDC # 54838-0550-80 manufactured by Lannett Company, Inc.This recall was issued 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.

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

The recall affects all unexpired lot numbers.

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 FDA has advised that patients taking prescription ranitidine should speak with their health care professional about other treatment options. 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.

CVS Caremark Response: Because of this action, CVS Caremark^® is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking Ranitidine Syrup 15mg/mL manufactured by Lannett Company, Inc. to contact their prescriber.

For more information about this recall, please contact Lannett Company, Inc. at 215-333-9000, extension 4. You may also contact the United States Food and Drug Administration (FDA) at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.fda.gov.