Drug Safety Alerts

Mylan Ranitidine Injection products Withdrawal

4/17/2020

On April 17, 2020, Mylan issued a notice that it is conducting a voluntary market withdrawal of ranitidine injection products. Mylan initiated the withdrawal of ranitidine injection products 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.

Mylan has issued this market withdrawal to the RETAIL LEVEL.

A complete list of Mylan ranitidine injection products is provided here.

CVS Caremark Response: Please note: These products are not carried by the CVS Caremark® Mail Service Pharmacies. Consistent with the FDA’s guidance, CVS Caremark Pharmacies will no longer be filling prescriptions for ranitidine products.

For more information about this withdrawal, please call Mylan at 1-800-796-9526. You may also contact the FDA consumer inquiry line at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.fda.gov.