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Novartis recalls Promacta

The product may be contaminated with peanut flour

Photo
Photo source: FDA
Novartis is recalling three lots of Promacta (eltrombopag) 12.5 mg for oral suspension.

The product may be contaminated with peanut flour.

There are no reports of adverse events to date related to this recall.

The recalled product is used 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.

The following lot numbers of the product are being recalled:

NDC

Number on Carton

NDC

Number

on Packet

Lot Num.Exp. Date

Dist.

Dates

0078-

0972-61

0078-

0972

-19

8H

579

015

89

09/

2020

1/2/19 – 2/11/19

0078-

0972-61

0078-

0972

-19

9H5

790

01

89

12/

2020

2/11/19 – 4/17/19

0078-

0972-61

0078-

0972-

19

9H5

790

02

89

12/

2020

3/6/19 – 4/2/19

The recalled product was distributed nationwide through specialty pharmacies.

What to do

Patients should stop taking the recalled product and consult with their healthcare provider.

They should also contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.

Novartis is notifying customers by letter and asking them to check for the recalled product and to return unused portion through directions provided in the recall letter.

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