Drug Safety Alerts

Ezetimibe 10 mg tablets and Losartan Potassium 50 mg tablets Patient-Level Recall

08/28/2019

On August 28, 2019, Sandoz issued a patient-level recall of Ezetimibe 10 mg tablets and Losartan Potassium 50 mg tablets. This action is not a result of any quality or safety concerns with the medications for their intended use. This recall was issued due to the cap and bottle combination for these items being not child resistant.

A complete list of the affected products and lot numbers is provided here:

The cap and bottle combination used to package particular lots of Ezetimibe 10 mg tablets and Losartan Potassium 50 mg tablets is not child resistant, posing a risk of harm if the tablets are swallowed by children. As a result, Sandoz is implementing a corrective action plan to the patient-level in the United States. Sandoz is offering a free replacement child resistant cap to pharmacies and patients having these particular lots of medication Please be aware that other lots of Ezetimibe 10 mg tablets distributed since April 2019 use a different cap; and are child resistant and comply with CPSC regulations. Sandoz last distributed the affected lot of Losartan Potassium 50 mg tablets in February 2019.

Patients should continue to take their medication as directed by their physician. However, due to the risk of harm in children, immediately secure the medication out of the reach and sight of children. Sandoz will provide patients with a free child resistant cap to secure their medication. Additional information regarding this recall is available at https://prod.us.sandoz.com.

CVS Caremark Response: Because of this action, CVS Caremark Mail Service Pharmacy is contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking Ezetimibe 10 mg tablets and Losartan Potassium 50 mg tablets to contact Sandoz.

For more information about this recall, please contact Sandoz at 1-800-525-8747, Monday through Friday, 8:30 am to 5:00 pm (ET) or visit www.us.sandoz.com. You may also call the U.S. Food and Drug Administration (FDA) consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov.