PlainRecalls
FDA Drug Critical Class I Terminated

Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo Pharmaceuticals, Inc. Whippany, New Jersey 07981 Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936 Product of Ireland, NDC 0078-0972-61.

Reported: May 29, 2019 Initiated: May 11, 2019 #D-1309-2019

Product Description

Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo Pharmaceuticals, Inc. Whippany, New Jersey 07981 Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936 Product of Ireland, NDC 0078-0972-61.

Reason for Recall

Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.

Details

Units Affected
792 cartons
Distribution
Nationwide with in the United States
Location
East Hanover, NJ

Frequently Asked Questions

What product was recalled?
Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo Pharmaceuticals, Inc. Whippany, New Jersey 07981 Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936 Product of Ireland, NDC 0078-0972-61.. Recalled by Novartis Pharmaceuticals Corp.. Units affected: 792 cartons.
Why was this product recalled?
Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.
Which agency issued this recall?
This recall was issued by the FDA Drug on May 29, 2019. Severity: Critical. Recall number: D-1309-2019.