Class II ยท Moderate risk
Temodar (temozolomide)
Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected during stability monitoring.
National Drug Code
Is NDC 0085-1519-02 recalled?
Temodar
Yes — this exact package was recalled
1 FDA recall names the code 0085-1519-02 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.
- Active ingredient
- Temozolomide
- Strength
- TEMOZOLOMIDE 20 mg/1
- Form
- Capsule · Oral
- Labeler
- Merck Sharp & Dohme LLC
- Type
- Human Prescription Drug
- Product code
- 0085-1519
Recalls naming this package
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
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