Novartis has announced a voluntary recall of three lots of Promacta (eltrombopag) 12.5 mg for oral suspension to the consumer level. The oral suspension lots are being recalled because of a risk of potential peanut flour contamination that occurred at a third-party contract manufacturing site.
Potential cross contamination with peanut flour, even in small traces, can cause allergic reactions.
The 12.5 mg liquid dose of Promacta 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.
Novartis is notifying its distributors and customers by letter and asking them to check for impacted product and to return unused product through directions provided in the recall letter.
Read the FDA announcement.