FDA Drug recall D-139-2013
Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administration, Rx Only, Cytotoxic, NDC: 0085-1519-02,…
- FDA Drug
- Class II
- terminated
- Published 2013-02-06
On 2013-02-06 the FDA classified a Class II recall of Temodar (temozolomide) Capsule, 20 mg per capsule, 5 capsules per package, For Oral Administration, Rx Only, Cytotoxic, NDC: 0085-1519-02,… by Schering Plough Products, citing failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification result in the degradation product testing detected during stability moni….
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-139-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2012-12-12 |
| Published | 2013-02-06 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Schering Plough Products |
| Distribution | US |
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
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.
Identifiers
| code_info | Lot: 0NCW005, Exp 02/2013 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-139-2013%22
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