Promacta Oral Suspension Recalled Due to Possible Peanut Contamination

Three lots of Promacta (eltrombopag; Novartis) for oral suspension 12.5mg are being recalled due to possible peanut flour contamination at a third-party manufacturer.

The recalled products have the following lot numbers, expiration dates, and distribution dates:

• 8H57901589, 09/2020, 1/2/19-2/11/19
• 9H57900189, 12/2020, 2/11/19-4/17/19
• 9H57900289, 12/2020, 3/6/19-4/2/19

The oral suspension is packaged in unit-dose packets containing a reddish-brown to yellow powder.

For patients with peanut sensitivity, ingestion of a product that may contain peanut flour could lead to hypersensitivity reactions, including life-threatening anaphylaxis. According to Novartis, no reports of adverse events have been received at this time.

Promacta, a thrombopoietin receptor agonist, is indicated for the treatment of: thrombocytopenia in patients with chronic immune thrombocytopenia; thrombocytopenia in patients with hepatitis C infection; and severe aplastic anemia.

The tablet formulation of Promacta is not impacted by the recall.

For more information visit novartis.com.