The recall sees three lots of oral suspension Promacta (eltrombopag) 12.5mg withdrawn from the consumer level.
A spokesperson for Novartis told us that the drug is manufactured for the company by Halo Pharmaceuticals, a contract manufacturer which is owned by Cambrex, after a $425m (€363m) acquisition last year.
In terms of how the potential cross-contamination came about, the spokesperson explained, “The third-party contract manufacturer introduced peanut flour into a pilot plant at its development site. This development site is located in the commercial manufacturing site for Promacta 12.5mg oral suspension.”
The step to recall was taken due to the risk of those hypersensitive to peanuts developing a reaction to the Promacta product.
Promacta is an oral suspension that is indicated for the treatment of paediatric and adults patients with chronic immune thrombocytopenia, certain adult patients with hepatitis C-associated thrombocytopenia, and certain adult and paediatric patients with severe aplastic anaemia who have not received prior immunosuppressive therapy or had an insufficient response to immunosuppressive therapy.
The recall does not extend Promacta tablets of 12.5mg, 25mg, 50mg, and 70mg strengths, with these products being manufactured in a different facility.
The spokesperson for Novartis confirmed that the company has not received any reports or adverse events related to the recall.
During its initial investigation, the spokesperson suggested that the risk of cross-contamination was low but could not be ruled out.
Novartis will work with Halo Pharmaceuticals to investigate how the potential incident occurred.
According to the Peanut Institute, estimates of the numbers of US citizens living with a peanut allergy ranges from 0.6%-1% of the population but this rises in children, with 2% of children potentially living with such an allergy.
