Novartis Recalls Three Lots of Promacta Due to Possible Peanut Contamination

By Patricia Van Arnum - DCAT Editorial Director

May 16, 2019

Novartis has announced a voluntary recall of three lots of Promacta (eltrombopag) 12.5 mg for oral suspension, a bone marrow stimulant, 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.

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. To date (as of May 11, 2019), Novartis says it 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.

Promacta 12.5 mg for oral suspension was distributed nationwide through specialty pharmacies. 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.

Source: Novartis and the US Food and Drug Administration