Class II · Moderate risk
Xolair (omalizumab injection)
CGMP Deviations - Product was exposed to temperatures outside the product's labeled storage requirements.
National Drug Code
Is NDC 50242-0215-01 recalled?
Xolair PFS
Yes — this exact package was recalled
1 FDA recall names the code 50242-0215-01 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.
1 of these recalls is still ongoing.
- Active ingredient
- omalizumab
- Strength
- OMALIZUMAB 150 mg/mL
- Form
- Injection, Solution · Subcutaneous
- Labeler
- Genentech, Inc.
- Type
- Human Prescription Drug
- Product code
- 50242-0215
Recalls naming this package
Class II · Moderate risk
Xolair (omalizumab)
Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content were detected at the 12 month testing time point.
Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.
Other recalled products from this labeler
- 50242-0041 Cathflo Activase 2
- 50242-0040 Xolair 1
- 50242-0064 See recall 1
- 50242-0074 See recall 1
- 50242-0076 See recall 1
- 50242-0078 Susvimo 1
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