Novartis has issued a voluntary recall of 3 lots of Promacta (eltrombopag) 12.5 mg for oral suspension to the consumer level, due to 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 and are not manufactured in the same facility, according to Novartis.

Peanut is a known food allergen that can cause reactions, including anaphylaxis, which can be fatal. Potential cross contamination with peanut flour, even in small traces, can lead to hypersensitivity reaction in patients with an unknown or known sensitivity to peanut antigen.

To date, Novartis has not received any reports or adverse events for this recall, according to the company.

Promacta 12.5 mg for oral suspension was distributed nationwide through specialty pharmacies. The affected product name, including the lot numbers and expiration dates, include:
  • Promacta for Oral Suspension, Lot 8H57901589, expiration 09/2020
  • Promacta for Oral Suspension, Lot 9H57900189, expiration 12/2020
  • Promacta for Oral Suspension, Lot 9H57900289, expiration 12/2020

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.

Consumers who have impacted product with these lot numbers and NDC numbers in their homes should contact 1-866-918-8772 (8:00 AM – 5:00 PM EST, Monday through Friday) for instructions on how to return recalled product. For all additional questions, please contact Novartis at 1-888-NOW NOVA (8:30 AM – 5:00 PM EST, Monday through Friday).

Consumers should stop taking Promacta 12.5 mg oral suspension and consult with their healthcare provider. Consumers should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Pharmacies that have impacted product with these lot numbers and NDC numbers should contact 1-866-918-8772 (8:00 AM – 5:00 PM EST, Monday through Friday) for instructions for return of recalled product.


Reference

Novartis Issues Voluntary Nationwide Recall of Promacta® 12.5 mg for Oral Suspension Due to Potential Peanut Contamination [news release]. Silver Spring, MD; May 12, 2019: FDA website. https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/novartis-issues-voluntary-nationwide-recall-promactar-125-mg-oral-suspension-due-potential-peanut?rel=0. Accessed May 2019.