Drug Safety Alerts

Pharmaceutical Associates, Inc. Ranitidine Syrup Products Withdrawal

4/07/2020

On April 7, 2020, Pharmaceutical Associates, Inc. issued a notice that it is conducting a voluntary market withdrawal of ranitidine syrup products at the request of the United States Food and Drug Administration (FDA). The FDA has announced that it is requesting manufacturers withdraw all prescription and over-the-counter (OTC) ranitidine drugs (commonly known by the brand name Zantac) from the market immediately. The Agency has determined that the impurity known as N-Nitrosodimethylamine (NDMA) in some ranitidine products increases over time and when stored at higher than room temperatures and may result in consumer exposure to unacceptable levels of this impurity.

Pharmaceutical Associates, Inc. has issued this market withdrawal to the RETAIL LEVEL.

A complete list of Pharmaceutical Associates, Inc. ranitidine syrup products is provided here.

CVS Caremark Response: Consistent with the FDA’s guidance, CVS Caremark Mail Service Pharmacies will no longer be filling prescriptions for ranitidine products, including Pharmaceutical Associates, Inc. ranitidine syrup products. CVS Caremark is in the process of contacting patients and prescribers to advise them of this withdrawal. We are encouraging patients who are using Pharmaceutical Associates, Inc. ranitidine syrup products to contact their prescriber.

For more information about this withdrawal, please call Pharmaceutical Associates, Inc. Drug Safety/Medical Affairs at 1‑877-993-8779, Monday through Friday, 9:00 am to 5:00 pm (ET) and select option 2. You may also contact the FDA consumer inquiry line at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.fda.gov.