Novartis Recalls Three Lots of Promacta

Novartis announced on May 11, 2019 that it was recalling three lots of Promacta (eltrombopag) 12.5 mg for oral suspension to the consumer level because of possible peanut flour contamination. The company reported that the possible contamination occurred at the third-party contract manufacturer, Halo Pharmaceuticals, which is owned by Cambrex. Contact with peanut flour by patients with an allergy to peanuts could lead to a hypersensitive reaction, including anaphylaxis, according to the company.

According to a statement from a representative of Novartis, "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 12.5 mg oral suspension. We are actively working with the manufacturer to investigate the potential cross contamination."

A company spokesperson told Pharmaceutical Technology that, "based on a detailed assessment and comprehensive investigation, the risk of cross contamination is low, but cannot be ruled out. As patient safety is our highest priority, we are recalling these lots in order to avoid any potential risk to patients. To date, Novartis has not received any reports or adverse events for this recall."

The recalled lots were distributed nationwide through specialty pharmacies. Affected lots include:

• Promacta for Oral Suspension, carton NDC number 0078-0972-61, packet NDC number 0078-0972-19, lot number 8H57901589, expiration date 09/2020

• Promacta for Oral Suspension, carton NDC number 0078-0972-61, packet NDC number 0078-0972-19, lot number 9H57900189, expiration date 12/2020

• Promacta for Oral Suspension, carton NDC number 0078-0972-61, packet NDC number
  0078-0972-19, lot number 9H57900289, expiration date
  12/2020.

Promacta tablets in 12.5 mg, 25 mg, 50 mg and 75 mg strengths are not manufactured at the same facility and are, therefore, not impacted by the recall.

Novartis is advising consumers to stop taking Promacta 12.5 mg oral suspension and contact their physician. Adverse events may be reported to FDA’s MedWatch program.

Promacta 12.5 mg for oral suspension is used to treat chronic immune thrombocytopenia, hepatitis C-associated thrombocytopenia, and severe aplastic anemia in patients who have not received prior immunosuppressive therapy or had an insufficient response to immunosuppressive therapy.

Source: FDA

This article was updated 11:15 AM EST, May 15, 2019 to include information about the third-party manufacturer and a statement from Novartis.