Recalls / Class I
Class ID-1309-2019
Class I— FDA's most serious classification, issued when there is a reasonable probability that use of or exposure to the drug will cause serious adverse health consequences 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.
- Brand name
- Promacta
- Generic name
- Eltrombopag Olamine
- Active ingredient
- Eltrombopag Olamine
- Route
- Oral
- NDCs
- 0078-0684, 0078-0685, 0078-0686, 0078-0687, 0078-0972, 0078-0697
- FDA application
- NDA022291
- Affected lot / code info
- Lot #: 8H57901589, Exp. 09/2020; 9H57900189 and 9H57900289, Exp. 12/2020.
Why it was recalled
Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.
Recalling firm
- Firm
- Novartis Pharmaceuticals Corp.
- Manufacturer
- Novartis Pharmaceuticals Corporation
- Notification channel
- Press Release
- Type
- Voluntary: Firm initiated
- Address
- 1 Health Plz, N/A, East Hanover, New Jersey 07936-1016
Distribution
- Quantity
- 792 cartons
- Distribution pattern
- Nationwide with in the United States
Timeline
- Recall initiated
- 2019-05-11
- FDA classified
- 2019-05-29
- Posted by FDA
- 2019-05-29
- Terminated
- 2023-11-28
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1309-2019. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.