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.

FDA recall notice · announced May 29, 2019 · Novartis Pharmaceuticals

Class I FDA/FSIS Class I: reasonable probability that use will cause serious adverse health consequences or death.

The product

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.

Notes

Distribution: Nationwide with in the United States
Lot/code information: Lot #: 8H57901589, Exp. 09/2020; 9H57900189 and 9H57900289, Exp. 12/2020.
Quantity: 792 cartons
Status: Terminated
Products in this recall event:
- 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 (D-1309-2019)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.