Drug Safety Alerts

Golden State Medical Supply Ranitidine Tablets Withdrawal

4/28/2020

On April 28, 2020, Golden State Medical Supply issued a notice that it is conducting a voluntary market withdrawal of ranitidine tablets. Strides Pharma, Inc., the manufacturer of these Ranitidine HCl Tablets, has advised Golden State Medical Supply that the market withdrawal was prompted by 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.

Golden State Medical Supply has issued this market withdrawal to the RETAIL LEVEL.

A complete list of Golden State Medical Supply 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 Golden State Medical Supply 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 Golden State Medical Supply ranitidine tablets to contact their prescriber.

For more information about this withdrawal, please call Golden State Medical Supply at 1-800-284-8633, Monday through Friday, 7:30 AM to 4:00 PM (PT). You may also contact the FDA consumer inquiry line at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.fda.gov.