Temodar — Class II drug recall D-139-2013
Terminated recall by Schering-Plough Products, LLC, reported 2013-02-06, distributed nationwide. Failed Impurities/Degradation Specifications: The recall is being initiated due to an out-of-specification res
| Recall number | D-139-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Schering-Plough Products, LLC, Las Piedras, PR, United States |
| Recall initiated | 2012-12-12 |
| Classified | 2013-01-30 |
| Reported by FDA | 2013-02-06 |
| Terminated | 2014-01-03 |
| Distributed | Nationwide (US) |
| Quantity | 17,169 packages |
| Reason classes | specification failure |
| NDC | 00085-1519-02 |
| Lot numbers | 0NCW005 |
| Expiration dates | 2013-02 |
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 for recall
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-139-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.