Drug Safety Alerts

Zydus Ranitidine Injection Products Withdrawal

4/03/2020

On April 3, 2020, Zydus issued a notice that it is conducting a voluntary market withdrawal of ranitidine injection products. Zydus initiated the withdrawal of these products on the request of the United States Food and Drug Administration (FDA). The FDA previously 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.

As ranitidine injection is indicated for short-term use in hospitalized patients, Zydus is conducting this market withdrawal to the HOSPITAL LEVEL.

A complete list of Zydus ranitidine injection 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 Zydus ranitidine injection 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 Zydus ranitidine injection products to contact their prescriber.

For more information about this withdrawal, please call Zydus 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.