Voluntary nationwide recall: Ocaliva (Intercept – September)

Intercept Pharmaceuticals, Inc. is voluntarily withdrawing Ocaliva^® (obeticholic acid) from the market. Ocaliva is used to treat a rare liver disease called primary biliary cholangitis (PBC).

This drug is being withdrawn because of concerns regarding the benefits versus the risks of taking it. This voluntary withdrawal followed a request from the U.S. Food and Drug Administration (FDA) to withdraw the drug.

If you are currently prescribed Ocaliva, you should consult your health care professional before making any changes. Intercept will provide additional information to support health care professionals and patients as it works with FDA on the transition process.

To learn more about this recall, you can take one or more of the steps below.

• Talk to your doctor or pharmacist.
• Patients can call Intercept’s Patient Support Services (Interconnect) at 1-844-622-4278. TTY users should call 711.
• Providers can contact Intercept Medical Information at medinfo@interceptpharma.com or call 1-844-782-4278.
• Visit Intercept’s website: OCALIVA: Withdrawal Process - Intercept Pharmaceuticals