FDA recall D-1309-2019

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.

Distribution

Nationwide with in the United States

Key facts

Status

Terminated

Initiation date

2019-05-11

Report date

2019-05-29

Termination date

2023-11-28

Voluntary/Mandated

Voluntary: Firm initiated

Location

East Hanover, NJ, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1309-2019