Drug Safety Alerts

Promacta® (eltrombopag) 12.5 mg for oral suspension Consumer-Level Recall

05/12/2019

On May 12, 2019, the United States Food and Drug Administration (FDA) issued a consumer-level recall of Promacta^® (eltrombopag) 12.5 mg for oral suspension manufactured by Novartis. This recall was issued because of a risk of potential peanut flour contamination that occurred at a third-party contract manufacturing site.

A complete list of the affected products is provided here.

Promacta tablets in 12.5 mg, 25 mg, 50 mg, and 75 mg strengths are not impacted by this recall and are not manufactured in the same facility.

Peanut is a known food allergen. Potential cross contamination with peanut flour, even in small traces, can lead to hypersensitivity reaction in a population of patients with an unknown or known sensitivity to peanut antigen, including a medically significant anaphylactic reaction, which can be fatal.

To date, Novartis has not received any reports or adverse events for this recall.

Promacta 12.5 mg for oral suspension is indicated for the treatment of certain adult and pediatric patients with chronic immune thrombocytopenia, certain adult patients with hepatitis C-associated thrombocytopenia, and certain adult and pediatric patients with severe aplastic anemia who have not received prior immunosuppressive therapy or had an insufficient response to immunosuppressive therapy. See www.promacta.com for full prescribing information.

CVS Caremark Response:

Please note: These products are not carried byCVS Caremark Mail Service Pharmacy.

For more information about this recall, please contact Novartis at 1‑888‑NOW-NOVA (1‑888‑669-6682) or visit www.novartis.com. You may also contact the FDA consumer inquiry line at 1-888-INFO-FDA (1-888-463-6332) or visit www.fda.gov/.