D-139-2013 Class II Terminated
FDA drug recall D-139-2013 was initiated by Schering-Plough Products, LLC on December 12, 2012 and is designated Class II. 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. The recall status is terminated (terminated January 3, 2014). Affected quantity: 17,169 Packages.
Recall Details
- Product Type
- Drugs
- Report Date
- February 6, 2013
- Initiation Date
- December 12, 2012
- Termination Date
- January 3, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 17,169 Packages
Product Description
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.
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot: 0NCW005, Exp 02/2013