May 29, 2019
Novartis Pharmaceuticals Corporation is recalling 792 cartons of Promacta (eltrombopag) 12.5 mg for oral suspension because the product may have been cross-contaminated with peanut flour, according to the May 29, 2019, US Food and Drug Administration (FDA) Enforcement Report.
“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,” the company stated in a press release. “To date, Novartis has not received any reports or adverse events for this recall.”
The recalled Promacta (NDC 0078-0972-61 on carton, NDC 0078-0972-19 on packet) was manufactured by Halo Pharmaceuticals Inc. and distributed by Novartis Pharmaceuticals to specialty pharmacies throughout the United States. Promacta included in the recall is from lots 8H57901589 (Exp. 9/20), 9H57900189 (Exp. 12/20), and 9H57900289 (Exp. 12/20).
Novartis Pharmaceuticals voluntarily initiated the recall May 11, 2019. At press time, the FDA had not yet issued a recall classification.
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.