Drug Safety Alerts

Strides Pharma Ranitidine Tablets Withdrawal

4/17/2020

On April 17, 2020, Strides Pharma Inc. issued a notice that it is conducting a voluntary market withdrawal of ranitidine tablets. Strides Pharma Inc. initiated the withdrawal of ranitidine tablets at the request of the United States Food and Drug Administration (FDA). The FDA has 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.

Strides Pharma Inc. has issued this market withdrawal to the RETAIL LEVEL.

A complete list of Strides Pharma Inc. ranitidine tablets 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 Strides Pharma Inc. ranitidine tablets. CVS Caremark is in the process of contacting patients and prescribers to advise them of this withdrawal. We are encouraging patients who are using Strides Pharma Inc. ranitidine tablets to contact their prescriber.

For more information about this withdrawal, please call Strides Pharma Inc. at 1-877-861-3811. You may also contact the FDA consumer inquiry line at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.fda.gov.