Novartis Recalls Promacta Oral Suspension Due to Peanut Cross-Contamination
Novartis is recalling Promacta (eltrombopag olamine) 12.5 mg oral suspension due to possible cross-contamination with peanut flour.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The FDA has classified this recall as Class I, which meets the rubric criteria for a Critical severity score (5).
Plain-English summary
Novartis Pharmaceuticals Corporation is recalling 792 cartons of Promacta (eltrombopag olamine) 12.5 mg for Oral Suspension. The recall is being conducted due to possible cross-contamination with peanut flour. The affected product is a prescription-only medication manufactured by Halo Pharmaceuticals, Inc. and distributed by Novartis Pharmaceuticals Corporation.
The recall covers specific lots: 8H57901589 (Exp. 09/2020), 9H57900189 (Exp. 12/2020), and 9H57900289 (Exp. 12/2020). The product was distributed nationwide in the United States. The FDA has classified this recall as Class I, indicating a reasonable probability that use of or exposure to the violative product may cause serious adverse health consequences or death.
Patients and healthcare providers should stop using the affected lots of Promacta and contact their healthcare provider for guidance. Consumers should check their medication packaging for the lot numbers and expiration dates listed above to determine if they are affected.
The recalled product
- Product
- PROMACTA (ELTROMBOPAG OLAMINE)
- Brand
- PROMACTA
- Manufacturer
- Novartis Pharmaceuticals Corp.
- Category
- Drug — Prescription Medication
- Affected units
- 792
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (4)
- Lot #: 8H57901589
- Exp. 09/2020
- 9H57900189 and 9H57900289
- Exp. 12/2020.
Distribution
Distributed nationwide across the United States.
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