Drug product
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
D-139-2013
Product summary
- Event
- Event 63879
- Status
- Terminated
- Classification
- Class II
- Quantity
- 17,169 Packages
- Official record key
drug-enforcement:D-139-2013
Official wording
Reason: 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.
Code information: Lot: 0NCW005, Exp 02/2013
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Potency or specification failure
out-of-specification