Class II · Moderate risk
Diovan (valsartan)
Failed Dissolution Specifications
Promacta (eltrombopag) (Eltrombopag Olamine)
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Cross Contamination with Other Products: product is being recalled due to possible cross-contamination with peanut flour.
Cause type: Cross-contamination
Traces of another drug - most often penicillin - got into the product from shared equipment or facilities. Even trace penicillin can trigger a severe allergic reaction in someone who was never meant to receive it. All cross-contamination recalls.
What was recalled
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.
Affected NDC
0078-0972-61
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Promacta eltrombopag olamine NDC 00078-0972 |
12.5 mg/1 | Powder, for Suspension Oral |
Novartis Pharmaceuticals Corporation | Rx |
- Recalling firm
- Novartis Pharmaceuticals Corp.
- NDC code
- 0078-0972-61
- Origin
- NJ, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1309-2019 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other recalls by Novartis Pharmaceuticals Corp.
All 2019 recalls
Class I · High risk
SANDIMMUNE Oral Solution
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals
Class I · High risk
SANDIMMUNE Oral Solution
Crystallization: bottles of Sandimmune Oral Solution were determined to contain crystals.
Class II · Moderate risk
Neoral soft gelatin capsules
CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.
Other cross-contamination recalls from 2019
All cross-contamination recalls
Class I · High risk
Lamotrigine Tablets
Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate.
Class II · Moderate risk
Petroleum jelly
Cross contamination with other products: undeclared contaminants of phenol and camphor in petroleum jelly tubes.
Class II · Moderate risk
Temozolomide Capsules
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
Class II · Moderate risk
Temozolomide Capsules
CGMP Deviations: product was manufactured that did not prevent possible cross contamination with beta lactam products.
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