Class II · Moderate risk
Product label: Temozolomide Capsules
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
Temodar (temozolomide)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
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.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administration, Rx Only, Cytotoxic, NDC: 0085-1519-02, Schering Corporation, Kenilworth, New Jersey, 07033
Affected NDC
0085-1519-02
Compare with the code on your package — it is the most precise check available.
Drug: Temozolomide
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 |
|---|---|---|---|---|
| Temodar Temozolomide NDC 00085-1519 |
20 mg/1 | Capsule Oral |
Merck Sharp & Dohme LLC | Rx |
- Recalling firm
- Schering-Plough Products, LLC
- Origin
- PR, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-139-2013 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Temozolomide recalls
See all
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.
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.
Other impurity / degradation recalls from 2012
All impurity / degradation recalls
Class III · Low risk
Femtrace 0.45 mg
Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
Class III · Low risk
Femtrace 0.9 mg
Failed Impurity/Degradation Specifications due to moisture ingress in individual bottles
Class III · Low risk
Caziant (desogestrel and ethinyl estradiol)
Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities.
Class III · Low risk
Perindopril Erbumine Tablets
Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
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