Drug Safety Alerts

Ondansetron® and Risperidone® Tablets Patient-Level Recall

7/5/18

On July 5, 2018, Sandoz issued a patient-level recall of Ondansetron^® 4 mg and 8 mg and Risperidone^® 0.5 mg, 1 mg, 2 mg, 3 mg and 4 mg orally disintegrating tablets (ODT). This action is not a result of any quality or safety concerns with these products. This recall was issued because the packaging for these products are not child-resistant which could pose 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. To avoid potential interruption of patients’ current supply of medication and dosing regimen, Sandoz is offering patients child-resistant pouches in which to store the affected drugs already in patients’ possession. This is an interim measure until child resistant packaging is available for household use.

A complete list of the affected products is provided at https://www.us.sandoz.com/patients-customers/product-safety-notices

CVS Caremark Response: Because of this action, CVS Caremark is in the process of contacting patients and prescribers to advise them of this recall. We are encouraging patients who are taking Ondansetron and Risperidone orally disintegrating tablets (ODT) products to contact Sandoz.

For more information about this recall, healthcare providers may contact Sandoz at 1‑888‑NOW-NOVA (1‑888‑669-6682), Monday through Friday 8:00 am to 8:00 pm (ET) and 9:00 am to 6:00 pm (ET) Saturday and Sunday or visit www.us.sandoz.com.

You may also call the U.S. Food and Drug Administration at 1‑888‑INFO-FDA (1‑888-463-6332) or visit www.fda.gov.