Drug 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.
D-1309-2019
Product summary
- Event
- Event 82820
- Status
- Terminated
- Classification
- Class I
- Quantity
- 792 cartons
- Official record key
drug-enforcement:D-1309-2019
Official wording
Reason: Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.
Code information: Lot #: 8H57901589, Exp. 09/2020; 9H57900189 and 9H57900289, Exp. 12/2020.
Distribution pattern: Nationwide with in the United States
Derived failure modes
-
Unknown
Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.