Novartis has begun 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.
Promacta tablets in 12.5 mg, 25 mg, 50 mg and 75 mg strengths are not impacted by this recall as they are not manufactured in the same facility.
Peanut is a known food allergen. 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.
As yet, Novartis has not received any reports or adverse events for this recall.
Promacta 12.5 mg for oral suspension was distributed nationwide through speciality pharmacies. Prescribed for the treatment of certain types of thrombocytopenia and anaemia.
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.