Status
Terminated
Drug Enforcement D-139-2013
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.
Classification
Class II
Report Date
February 6, 2013
Termination Date
January 3, 2014
Product Information
- 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
- Product quantity
- 17,169 Packages
- 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.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- Nationwide and Puerto Rico
Location & Firm
- Recalling firm
- Schering-Plough Products, LLC
- Address
-
Pridco Industrial Park, Road # 183
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-139-2013
- Event ID
- 63879
- Recall initiation date
- December 12, 2012
- Center classification date
- January 30, 2013
- Code info
- Lot: 0NCW005, Exp 02/2013
- More code info
- —