Drug Safety Alerts

Ajanta Pharma Ranitidine Capsules Withdrawal

4/16/2020

On April 16, 2020, Ajanta Pharma issued a notice that it is conducting a voluntary market withdrawal of ranitidine capsules. Ajanta Pharma initiated the withdrawal of ranitidine capsules at 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, which may result in consumer exposure to unacceptable levels of this impurity.

Ajanta Pharma has issued this market withdrawal to the RETAIL LEVEL.

A complete list of Ajanta Pharma ranitidine capsules 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 Ajanta Pharma ranitidine capsules.

CVS Caremark is in the process of contacting patients as well as their prescribers to advise them of this market withdrawal. We are encouraging patients who are taking Ajanta Pharma ranitidine capsules to contact their prescriber.

For more information about this withdrawal, please call Ajanta Pharma at 1-855-664-7744. You may also contact the FDA consumer inquiry line at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.fda.gov.