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Recall Active for Promacta
“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.
—Jolynn Tumolo