FDA Recall D-1309-2019
Novartis Pharmaceuticals Corp. · East Hanover, NJ
Class I — life-threatening Terminated 1662 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-1309-2019- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Press Release
- Distribution
- Nationwide with in the United States
- Recall initiated
- 2019-05-11
- Classified by FDA Center
- 2019-05-29
- FDA published
- 2019-05-29
- Terminated
- 2023-11-28
- Recalling firm
- Novartis Pharmaceuticals Corp.
- Firm location
- East Hanover, NJ
Drug identification
- Brand name(s)
- PROMACTA
- Generic name(s)
- ELTROMBOPAG OLAMINE
- Manufacturer(s)
- Novartis Pharmaceuticals Corporation
- NDC(s)
0078-0684, 0078-0685, 0078-0686, 0078-0687, 0078-0972, 0078-0697- Route(s)
- ORAL