FDA Drug recall D-1309-2019
Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo Pharmaceuticals, Inc
- FDA Drug
- Class I
- terminated
- Published 2019-05-29
On 2019-05-29 the FDA classified a Class I recall of Promacta (eltrombopag) 12.5 mg for Oral Suspension, Rx Only Manufactured by: Halo Pharmaceuticals, Inc by Novartis Pharmaceuticals, citing cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1309-2019 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2019-05-11 |
| Published | 2019-05-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Novartis Pharmaceuticals |
| Distribution | US |
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
Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.
Identifiers
| ndc | 0078-0684-15 |
|---|---|
| ndc | 0078-0685-15 |
| ndc | 0078-0686-15 |
| ndc | 0078-0686-55 |
| ndc | 0078-0687-15 |
| ndc | 0078-0972-19 |
| ndc | 0078-0972-23 |
| ndc | 0078-0972-61 |
| ndc | 0078-0697-19 |
| ndc | 0078-0697-23 |
| ndc | 0078-0697-61 |
| code_info | Lot #: 8H57901589, Exp. 09/2020; 9H57900189 and 9H57900289, Exp. 12/2020. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1309-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.